Quality manager jobs in Bethlehem, PA - 76 jobs

Title: Inventory Quality Specialist About Midea Midea Group is one of the world's largest home appliance brand, offering the most comprehensive selection of products in the world to fully serve the needs of day-to-day living at home, at work, or anywhere else you go. We strive to aim high, put the customer first, transform and innovate the marketplace, utilizing our commitment, dedication, inclusion and partnership with our teams. Midea is a global company operations in more than 195 countries. As a publicly listed company, we are also ranked #245 as a Fortune Global 500 company and offers one of the most comprehensive ranges in the home appliance industry. Midea America is a subsidiary of Midea Group in the US. Job Summary Midea America is seeking a highly organized, detail-oriented Warehouse Inventory Controller to support inventory accuracy, quality, and control within our regional distribution center in Pennsylvania. This role is critical to ensuring system integrity, physical inventory accuracy, and compliance with customer, financial, and operational requirements. The Inventory Controller owns inventory governance across the DC-overseeing audits, discrepancy resolution, rework and returns, aged inventory management, and WMS execution. This role partners closely with Warehouse Operations, Finance, Quality, Reverse Logistics, Compliance, and third-party logistics providers (3PLs) to ensure inventory accuracy, accountability, and continuous improvement. Essential Job Responsibilities Inventory Accuracy & Control Lead and oversee physical inventories and cycle counts; plan, schedule, and execute mid-year and year-end inventory audits. Investigate, reconcile, and resolve inventory discrepancies (shorts, overages, damages, loss) in a timely and accurate manner. Ensure all inventory adjustments are supported by root cause analysis and properly executed in the WMS. Monitor shrink-related incidents (damaged product, dropped pallets, losses) and ensure real-time system updates while holding 3PLs accountable per contractual terms. Review and correct inventory imbalances using systematic in-house transfers. Quality, Compliance & Rework Oversee isolation and disposition of returned, recalled, quarantined, and rework inventory. Direct warehouse staff on corrective actions leading to final stock resolution (A-Stock, liquidation, scrap). Conduct inventory quality audits, including inventory accuracy, damaged product segregation, and outbound quality standards (pallet integrity, overhang, wrapping, strapping, and load securement). Partner with Midea Compliance and customer portals to reduce chargebacks and compliance penalties. Ensure DC teams follow SOPs for receiving discrepancies, shortages, and damage documentation. WMS & Master Data Management Ensure proper WMS execution to maintain inventory accuracy and visibility. Manage item master attributes including TI-HI, stack height, pallet configuration, inventory grade, and demand type. Recommend optimal placement strategies for seasonal, e-commerce, rework, and quarantined inventory. Generate and manage RMAs to support reverse logistics and systematic receiving processes. Operational Support & Reporting Respond promptly to inventory-related inquiries from Operations, Order Management, Sales, Procurement, Quality, Reverse Logistics, Finance, and Senior Leadership. Monitor and report on inventory turns, aged inventory, seasonal readiness, and high-velocity e-commerce SKUs. Communicate rework timelines, costs, and quality issues to Finance and cross-functional stakeholders. Monitor productivity of quality and rework labor to ensure value-added work is completed on time and within budget. Safety & Supply Management Communicate and enforce all safety policies; conduct self-audits to ensure compliance. Maintain warehouse supply inventory (pallets, stretch wrap, labels, etc.) and track usage levels. Required Qualifications Bachelor's degree in Logistics, Supply Chain Management, or a related field (required). Minimum of 5 years of experience in a warehouse or distribution environment (preferred). At least 5 years of supervisory or lead-level experience (preferred). Strong working knowledge of Warehouse Management Systems (WMS); YMS experience preferred. Advanced proficiency in Microsoft Excel; strong skills in PowerPoint and Word. Excellent written and verbal communication skills with the ability to collaborate cross-functionally. Strong planning, organization, and problem-solving capabilities. Ability to operate effectively under pressure in a fast-paced, changing environment. Customer-focused mindset with a high level of ownership and accountability. Ability to spend extended periods on the warehouse floor while adhering to all safety requirements. Must be authorized to work in the United States. Featured benefits Insurance package. 401(k). Work life balance. Comprehensive benefit package, to learn more, please visit Careers Page (midea.com) Midea America Corp. is an equal opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics

Primary Duties & Responsibilities Lead SiC LLC Quality Function Build strong organization quality talent in SiC LLC plants. Actively engage in resolving customer quality issues and prepare for customer audits. Drive total customer satisfaction. Coach the plants towards a culture of prevention. Establish strategic quality direction within the plants. Teach advanced Quality classes at the plants. Establish a culture of intelligent risk-taking and guide the plants in choices to help exploit strategic opportunities. Lead in strategic decision-making, and in tactical decision making within important risk-saturated areas. Ensure Quality systems are aligned with identified best-practices. Lead and manage the quality functions at SiC LLC plants. Design and lead production of various dashboards accurately depicting quality product and process status in all plants. Create and Maintain QMS Alignment with the Coherent Global Quality System Ensure Quality Manual aligns with Coherent Corporate Global Quality manual. Establish and maintain a process for “Preventive Action Efficiency” to drive mistake-proofing in the factories. Implement and maintain Coherent Global COQ process. Implement and maintain coherent Global KPI process. Implement and maintain Coherent Global QBR. Implement and maintain Coherent Global Risk Assessment process. Implement and maintain the Coherent Global QAT-based assessment QMS effectiveness. Implement and maintain Coherent Global Purge process. Implement and maintain Coherent Global Quality Stop process. Implement and maintain Coherent Global NPI process. Implement and maintain Coherent Global PCN process. Lead the Development and Implementation of IAFT 16949 QMS Conceive, design, develop, implement, and continually improve an IATF 16949 certified QMS. Lead efforts to identify, develop, proceduralize, and implement best quality AIAG practices in all SiC LLC plants. Guide best practice design and deployment of processes for PPAP, SPC, MSA, APQP, and FMEA. Implement Coherent Corporate Global internal quality audit process to ensure continual compliance and improvement of the automotive QMS. Design and implement periodic Management Review processes to drive continual improvements. Implement the Coherent Corporate Global 8D corrective action database and ensure its optimum usage. Develop and maintain a Quality Manual. Implement and maintain key complimentary processes within SiC LLC Export compliance is maintained. Ensure implementation and maintenance of Coherent Lean process. Implement and maintain necessary ESD processes. Implement and maintain necessary ESG processes. A quality work environment consistent with 6S practices is maintained. Assure regulatory compliance in product-related areas such as RoHS, REACH, and Conflict Minerals. Education & Experience M.S. in technical field, preferably Statistics, Mathematics, or Industrial Engineering. Extensive experience with Quality Sciences and Quality Management. 20 years Quality Engineering, Quality Management, or Quality Consulting. 15 years of experience electronics or semiconductor manufacturing. 20 years of experience in internal quality audit. 10 years of experience managing tier-1 or tier-2 customer audits. 10 years of experience in using structured techniques to solve complex problems. Awareness of PPAP, FMEA, MSA, Control Plan, and SPC techniques. Awareness of lean manufacturing techniques. Due to ITAR compliance, this position requires candidates to be a U.S. Citizen, Permanent Resident Alien, or Protected Individual per 8 U.S.C. 1324b(a)(3). Skills & Other Requirements Expert Knowledge of the ISO 9001 criteria. Awareness and understanding of the IATF 16949 criteria. Process characterization and control techniques. Able to balance financial and quality objectives. Statistical expertise including FMEA, SPC, DOE, MSA, Process Capability. Able to understand AIAG process control plans. Able to facilitate cross-functional Kaizen Events. Solve complex problems using intuition, induction, deduction, analysis of data, and advanced quality tools, and structured problem-solving methods. Effectively work in cultures throughout North America, Europe, and Asia. Able to think critically and to reengineer all elements of an Automotive Quality System to remove waste of time and dollars, while increasing Quality performance. Willing to take intelligent risks to gain opportunities for quality innovation. Excellent interpersonal, communication and presentation skills and ability to comprehend and communicate at a high level with executives, senior managers, and global customers, suppliers, and principals at different sites. Able to relate well and work collaboratively with all levels within a site, from senior leaders to production operators. Ability to deal effectively with differences of opinion, to influence, to draw ideas from others, and to negotiate and mediate. Ability to anticipate and handle multiple priorities and complex/abstract issues involving external and internal priorities. Ability to excel in a cross-organizational, cross-cultural, global team environment and to easily adjust in the face of challenge and change. Handle special assignments promptly and professionally. Maintain a high standard of ethics, professionalism, leadership, and competency. Proven ability to lead and motivate people. Demonstrates and promotes the Coherent ICARE Worldwide Values. Knowledgeable in worldwide ESG norms. Working Conditions Office Environment Manufacturing Plant Environment, on occasion Physical Requirements Ability to work at computer Safety Requirements All employees are required to attend scheduled training, follow the site EHS procedures and Coherent Corporate EHS standards. This includes the use of proper protective equipment (PPE) as required by the job responsibilities. Managers will ensure that all safety and environmental procedures are followed consistently. They will ensure that risk assessments are performed, proper training, work instructions, required PPE is available, and will monitor compliance. Quality & Environmental Responsibilities Depending on location, this position may be responsible for the execution and maintenance of the ISO 9000, 9001, 14001 and/or other applicable standards that may apply to the relevant roles and responsibilities within the Quality Management System and Environmental Management System. Culture Commitment Ensure adherence to company's values (ICARE) in all aspects of your position at Coherent: Integrity - Create an Environment of Trust Collaboration - Innovate Through the Sharing of Ideas Accountability - Own the Process and the Outcome Respect - Recognize the Value in Everyone Enthusiasm - Find a Sense of Purpose in Work

The Senior Manager of QA leads one or more QA teams supporting designated functional areas of Packaging Operations or Central functions (i.e., Facilities, Warehouse, Project and Account Management, Engineering, IT, Incoming Inspection and Documentation) in a contract pharmaceutical packaging facility. The position provides quality oversight, regulatory and cGMP guidance to designated areas within Sharp US Commercial Sites. Responsibilities include, but are not limited to, supervision of quality related activities, troubleshooting quality related issues, making quality decisions regarding issue resolution, and driving continuous quality improvements. This position is responsible for ongoing contact with customer QA representatives regarding quality non-conformances, investigations, change controls, CAPAs, documents, quality metrics, customer quarterly business reviews, audits and audit follow-up related to their designated functional areas. This position is responsible to assist the Sharp audit team and help prepare area owners to lead discussions and tours relevant to their designated areas during customer and/or regulatory agency inspections and work with internal partners to lead and/or drive subsequent actions. The Senior Manager Quality is responsible to ensure both internal and external customers receive the appropriate level of quality support and will serve as the second level of escalation for customer issues or concerns. The scope of the position includes Allentown, Macungie and/or Conshohocken. The impact of decisions relating to customer interface, quality issues and documentation requirements could expose the company to significant risk or economic loss. ESSENTIAL DUTIES AND RESPONSIBILITIES: The following is a list of minimum responsibilities related to the Senior Manager QA position. Other duties may also be assigned. Leads one or more QA teams associated with designated functional areas of Packaging Operations or Central functions (i.e., Facilities, Engineering, Warehouse, Packaging Services, Incoming Inspection, Documentation, etc.) Responsible for ensuring products and processes meet customer, company and regulatory requirements/standards and participating in internal, regulatory and customer audits as required. Responsible for delivering internal and customer quality KPIs and standards for assigned areas. Responsible for leading and coaching teams through problem-solving initiatives and impact assessments associated with change management and non-conformances as well as the review and approval of quality related documentation. Serve as an escalation point for customers and serve as backup for the site Quality lead during absences. Summarize data, draw conclusions, and turn recommendations into clear actions which can be effectively communicated across all levels of the organization. Identify and lead implementation of continuous improvement opportunities of broader impact (i.e., site or division level). Support designated area to ensure compliance to processes and products and ensure testing, inspection and monitoring programs meet all requirements. Responsible for implementation of initiatives related to quality systems gap resolutions as well as quality improvements. Responsible for contributing to and driving attainment of the short- and long-term quality strategy by understanding the future needs, relative to the required skills and resources needed, to successfully support the business. Responsible to work across the broader quality organization to meet future needs through succession planning, training, development and mentoring of personnel. Responsible to effectively communicate a variety of personnel actions, including but not limited to, employment, termination, performance, discipline, scheduling, and salary review. Performs other related duties as required. by management. QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. SUPERVISORY RESPONSIBILITIES: Direct supervision of quality managers and professionals at the local site. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE: Bachelor's degree in science is preferred with seven to ten years of related experience or Associate's degree with ten to fifteen years of related experience or a minimum of fifteen years of related experience. Knowledge of current FDA regulations and current industry practice Thorough knowledge of quality and/or operations required. Knowledge of DEA regulations desired. Broad knowledge of current pharmaceutical industry including packaging practices Above average written and oral communication skills required. Above average organizational and planning skills required. PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The employee frequently is required to sit. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus. WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is normally required to sit at a desk or periodically go onto the shop floor. The working environment is clean and not normally subject to hazardous environment or conditions. Approximately 5-10 percent auto travel between sites. Travel to customers on an as needed basis. DISCLAIMER: This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.

We are currently on a hunt for a Quality Manager to join our client's team in Bethlehem, PA. What you'll be doing: You will lead the overall quality direction of this World Wide Food company and will be involved in every aspect of overseeing quality. Will lead the development and execution of all Quality Assurance programs and activities that ensure compliance with company policies, food safety standards, government regulations, and industry best practices including GMP, SQF and HACCP. Will edit and develop HACCP plans and strategies for new products. Maintain current library for all GMPs, SOPs, SQF. Qualifications We would love to hear from you if : 4+ years of experience in QA food processing and packaging experience. You must have SQF experience. BS/Masters in Food Science, Microbiology, engineering Must have extensive experience with FDA. PS:Excellent Base Pay + Great Benefits + Relocation Pay. We embrace diversity and equal opportunity in a serious way. Additional Information All your information will be kept confidential according to EEO guidelines.

Step into a pivotal leadership role at Clemens Food Group, where your impact on food safety, people leadership, and product quality will be seen daily. Internally, this role is called a Superintendent, but externally we're seeking an Assistant FSQA Manager-a role often known in other organizations as a Food Safety Manager, Quality Assurance Manager, or FSQA Manager. In this role, you'll lead a team of QA supervisors and technicians in a USDA-regulated meat processing facility, ensuring compliance with HACCP, SSOPs, GMPs, and audit readiness. As the senior-most FSQA authority on second shift, you'll balance hands-on floor leadership with root cause analysis, corrective actions, and continuous improvement projects in one of our largest protein production plants. Shift Details Shift starts at 3:00 PM and runs for 9 hours As a management-level position, flexibility is expected-shifts may start or end an hour earlier or later based on operational needs On-call approximately one out of every four weekends The Impact You'll Make You'll own the shift. Literally. From running handoffs and leading root cause investigations to coaching your team and making critical decisions during audits or equipment failures-this role gives you end-to-end visibility and influence. Your leadership will drive our KPIs around safety, first pass quality, and regulatory compliance. What You'll Do Lead and develop a second-shift FSQA team (multiple supervisors and techs) Be the point of contact for USDA, customer complaints, and urgent investigations Review and act on trend data to improve quality and reduce CPMs Collaborate cross-functionally with Ops, R&D, and Sanitation Manage issue resolution, floor presence, audits, and on-call response (1 in 4 weekends) Prioritize food safety and people leadership at every turn What Makes This Role Exciting? You're the top FSQA decision-maker on your shift Gain experience in a high-capacity, 1.3M sq. ft. protein facility Every day brings new projects, challenges, and growth moments Room to grow-this role is a stepping stone to FSQA Manager What We're Looking For Proven FSQA leadership, meat/poultry/seafood industry required Proven ability to lead teams and manage performance Strong background in USDA, HACCP, audits, and corrective actions Comfortable with ambiguity, fast pace, and solving complex floor issues Skills & Mindset High initiative: confident in making decisions without constant direction Project-focused: can organize chaos into action plans and results People-first: builds trust, holds people accountable, and develops others Strong communicator: connects across functions, listens well, and presents data clearly Your Future at Clemens This isn't just a shift job-it's a career-building leadership role. We'll support your onboarding, help you get grounded in our culture, and give you visibility that sets the stage for broader advancement within FSQA. Application Note: Clemens Food Group is not accepting unsolicited resumes from search or staffing firms. All resumes submitted by search or staffing firms to any employee at Clemens Food Group via email, the Internet, or directly without a valid written search agreement for this role, and without having been asked to participate in this by Talent Acquisition, will be deemed the sole property of Clemens Food Group, and no fee will be paid in the event the candidate is hired. Firms not authorized to submit candidates will not be eligible for any fee or ownership claim. #LG-AG1 Keywords Food Safety, Quality Assurance, Food Safety Supervisor, FSQA Manager, Assistant Food Safety Manager, Meat Processing QA, USDA Compliance, HACCP, SQF, Food Manufacturing, Protein Industry, QA Team Leader, Quality Systems, Food Safety and Sanitation, Second Shift Food Safety, Regulatory Compliance, Food Plant QA, FSQA Superintendent, Assistant QA Manager. #LI-AG1

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description: The correct title for this position is Clinical Quality Manager. Role Description The Clinical Quality Manager (CQM) is responsible for driving Asset and Study level quality management for specific assets primarily in the Alliance Partner (AP) model by maintaining 'quality' line-of-sight from Asset to Clinical Investigator Site level. • With this focus, the CQM role brings deep knowledge for asset- and study-level quality across clinical trial business process areas. In partnership with the Dev Ops Asset Lead and BU Clinical Lead, the CQM will ensure study level quality oversight, manage relevant Asset and Study level quality issues, and will be instrumental in ensuring that Asset and Study level information is appropriately incorporated within the GCP QMS. Act as point person to stakeholders and asset teams for asset and study quality risk management and quality issues management. • CQM may also continue to provide additional centralized services as described below as necessary. Responsibilities As CQMs are assigned to specific Asset, responsibility includes: Facilitate IQMP Development and Oversight of IQMP (Integrated Quality Management Plan) at study and asset level including integration within the Quality Management System (QMS) Facilitate study-level quality risk management activities (including IQMP activity) • Drive consistent implementation of IQMP across study-teams Facilitate IQMP development to ensure that study teams: Identify factors that are critical to quality and pre-specify appropriate quality metrics Identify high priority risks to quality and prospectively implement appropriate mitigation plans • Facilitate IQMP implementation, via participation on the asset clinical operations team, by ensuring that quality metrics are monitored and that quality deviations are identified and addressed in a timely and appropriate manner. Utilize QMS information, and integrate findings back into QMS, share learnings across assets and across CQM team Provide feedback to IQMP BPO to continuously improve IQMP approach Quality Gate and/or Quality Compliance Assessments Perform quality gate assessments (e.g. quality, completion or compliance assessment of key quality elements (e.g. prior to study start-up, during conduct phase, and study closeout) • Perform asset or study-focused quality compliance assessments Track compliance or performance against expectations, and manage outcomes Asset Clinical Quality Management Facilitate study-level quality risk management activities (including IQMP activity) Maintain comprehensive portfolio of quality issues across Asset Provide quality management / operational expertise Review quality reports and metrics for asset/study implications and remediation needed; to identify useful knowledge to apply/share cross-functionally IQMP PSQRV visit information for trends across asset Significant deviations/qualifying quality issues (QQI) across asset • Audit/Inspection Metrics Audit and/or CAPA Trend reports Protocol Deviations Metrics and Trends Guide asset/study team on appropriate quality remediation actions, facilitates remediations, and tracks/ensures completion in close collaboration with DevOps Asset Lead and BU Clinical Lead (e.g. remediation for pervasive cross-asset protocol deviation issues) • Ensure timely progress and completion for quality activities for which study teams/Alliance Partner are responsible per Clinical Trial Process Quality Standards (CTPQS): (e.g. Audit CAPA completion, study level quality issue action tracking, inspection readiness) Participates on QQI teams to provide guidance on actions to address quality issues (e.g. issuance of Protocol Deviation Alert Letters (PDAL), or actions to address QQI) May attend governance meetings and provide knowledge/trend information as appropriate • Perform Root Cause Analysis (RCA) for ad hoc asset quality issues Participate and guide team with Inspection conduct and response activity Maintain line-of-sight to asset quality issues where studies within asset are in multiple models (e.g. AP model, Maintained portfolio) Escalation, Communication, and Governance Guides asset/study team on appropriate escalation pathways Communicates/Escalates Asset / Study quality issues to: Asset-level roles (e.g. DevOps Asset Lead, Clinical Lead) Governance committees as necessary (e.g. QCC, QOC) BPOs for process level issues Alliance Partner Quality group/roles for potential qualifying quality issues as applicable Communicates study team continuous improvement feedback on business processes to BPOs Communicates key quality information (e.g. inspection/audit learnings) across asset/study teams and may serve as asset quality expert and liaison to relevant governance meetings • Lead or participate in quality-focused meetings for Asset Teams Perform other quality management related or oversight tasks as assigned CQMs may be responsible to provide other CQM centralized services which may include: Quality Compliance Assessments Lead / Contribute to Quality and Compliance Assessments (QCA) planning, conduct and report-out Line Compliance and SOP Review Coordinate and may manage the DevOps Compliance Plan (ADM02); ensure CTPQ training compliance Contribute to the review of new and revised SOPs to determine impact on DevOps business and compliance capability Audit Coordination Point of contact within DevOps and for internal audit groups for process audit planning, conduct and response support; may serve as DevOps/Clinical Audit Coordinator; track Dev Ops / Clinical process audit CAPAs; provide Audit Schedule Root Cause Analysis Facilitation May lead or participate in Root Cause Analysis for ad hoc requests Inspection Readiness Develop and lead strategy for and/or provide Study Team Inspection Readiness (IR) guidance and support; leads teams through pre-submission IR deep-dive Act as CQM Inspection Readiness contact for study teams via the CPM line Inspection • Support Acts as lead point of contact or supports the lead/main CQM point of contact within DevOps and for MQA when regulatory inspections are announced Coordinates or supports coordination of resources within DevOps/Clinical to ensure successful inspection outcomes and CAPA management for inspection commitments, communicates inspection progress and needs to DevOps/Clinical stakeholders QQI/CAPA Management: Acts and/or supports CAPA Mgmt lead as business line quality group for CAPA Management of Dev Ops / Clinical CAPAs . • Ensures or supports compliance with CAPA process QQI Case Management o Will or may function as QQI Case Lead: management for Significant Deviations, including investigation/root cause analysis and action development, tracking, and documentation Qualifications Training & Education Preferred: Degree in one of the disciplines related to drug development or business. Advanced or comprehensive knowledge, experience and expertise in clinical trial development, and operational quality management disciplines such as, quality and compliance assessments, quality assurance, CAPA management, deviation management, root cause analysis, audit and regulatory inspection process, and/or inspection readiness. • Prior Experience Preferred Advanced or comprehensive clinical trials experience, especially operational processes and/or systems. Advanced or comprehensive Quality Management experience including use of metrics to drive quality and compliance Excellent understanding of Pharmaceutical processes and SOPs Skilled in project management Strong influencing skills with ability to influence a broad range of global stakeholders. Strong interpersonal skills and ability to build and maintain excellent working relationships across lines in a matrix organization Experience of drug development across one or more business lines Experience of working on global initiatives or project teams. Appreciation of diverse needs of different regulatory requirements of different sites and countries Ability to work successfully with internal and external partners • Excellent communication skills adaptable to meet the needs of diverse stakeholder groups Experience of conducting, managing or participating in an audit and/or inspection process Record of achievement and delivery for personal and team goals Ability to balance and prioritize a diverse and demanding workload Works independently and proactively set own work agenda with minimum guidance Competencies: Advanced or comprehensive knowledge in clinical trial development Able to use metrics and related data to determine where quality issues may exist and address appropriately Advanced or comprehensive experience in Quality areas such as: Quality management, quality compliance assessments, audit, inspection, compliance, CAPA management, and inspection readiness fields Knowledge of Pharmaceutical process in these areas • Project Management skills/experience Ability to provide guidance and instruction in Inspection Readiness and consultation for audit responses Knowledge of ICH GCP and regulations in order to assess GCP situations and coordinate resolution activities across partner lines Knowledge of Pharmaceutical SOPs and processes Ability to implement strategies using coordinated and transparent metrics to track and manage compliance Ability to lead cross-line global initiatives or root-cause analysis for quality related process improvement"Facilitate IQMP • Development and Oversight of IQMP (Integrated Quality Management Plan) at study and asset level including integration within the Quality Management System (QMS) " Quality Gate and/or Quality Compliance Assessments Asset Clinical Quality Management " Advanced or comprehensive clinical trials experience, especially operational processes and/or systems. Qualifications Advanced or comprehensive Quality Management experience including use of metrics to drive quality and compliance Excellent understanding of Pharmaceutical processes and SOPs Skilled in project management " Skills Skills Skills:Category Name Required Experience Areas of Expertise Compliance Yes 6 + Years Technical Skills Quality Audit Reports Yes 6 + Years Additional Skills:Advanced knowledge of Clinical Trial development required. Minimum of Bachelors Degree required. Advanced degree preferred. Additional Information Sneha Shrivastava Technical Recruiter (Clinical/Scientific) Artech Information Systems LLC 360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 Office: ************ | Fax: ************ Connect with us on - LinkedIn | Facebook | Twitter

Primary Duties & Responsibilities * Lead SiC LLC Quality Function * Build strong organization quality talent in SiC LLC plants. * Actively engage in resolving customer quality issues and prepare for customer audits. Drive total customer satisfaction. * Coach the plants towards a culture of prevention. * Establish strategic quality direction within the plants. * Teach advanced Quality classes at the plants. * Establish a culture of intelligent risk-taking and guide the plants in choices to help exploit strategic opportunities. * Lead in strategic decision-making, and in tactical decision making within important risk-saturated areas. * Ensure Quality systems are aligned with identified best-practices. * Lead and manage the quality functions at SiC LLC plants. * Design and lead production of various dashboards accurately depicting quality product and process status in all plants. * Create and Maintain QMS Alignment with the Coherent Global Quality System * Ensure Quality Manual aligns with Coherent Corporate Global Quality manual. * Establish and maintain a process for "Preventive Action Efficiency" to drive mistake-proofing in the factories. * Implement and maintain Coherent Global COQ process. * Implement and maintain coherent Global KPI process. * Implement and maintain Coherent Global QBR. * Implement and maintain Coherent Global Risk Assessment process. * Implement and maintain the Coherent Global QAT-based assessment QMS effectiveness. * Implement and maintain Coherent Global Purge process. * Implement and maintain Coherent Global Quality Stop process. * Implement and maintain Coherent Global NPI process. * Implement and maintain Coherent Global PCN process. * Lead the Development and Implementation of IAFT 16949 QMS * Conceive, design, develop, implement, and continually improve an IATF 16949 certified QMS. * Lead efforts to identify, develop, proceduralize, and implement best quality AIAG practices in all SiC LLC plants. * Guide best practice design and deployment of processes for PPAP, SPC, MSA, APQP, and FMEA. * Implement Coherent Corporate Global internal quality audit process to ensure continual compliance and improvement of the automotive QMS. * Design and implement periodic Management Review processes to drive continual improvements. * Implement the Coherent Corporate Global 8D corrective action database and ensure its optimum usage. * Develop and maintain a Quality Manual. * Implement and maintain key complimentary processes within SiC LLC * Export compliance is maintained. * Ensure implementation and maintenance of Coherent Lean process. * Implement and maintain necessary ESD processes. * Implement and maintain necessary ESG processes. * A quality work environment consistent with 6S practices is maintained. * Assure regulatory compliance in product-related areas such as RoHS, REACH, and Conflict Minerals. Education & Experience * M.S. in technical field, preferably Statistics, Mathematics, or Industrial Engineering. * Extensive experience with Quality Sciences and Quality Management. * 20 years Quality Engineering, Quality Management, or Quality Consulting. * 15 years of experience electronics or semiconductor manufacturing. * 20 years of experience in internal quality audit. * 10 years of experience managing tier-1 or tier-2 customer audits. * 10 years of experience in using structured techniques to solve complex problems. * Awareness of PPAP, FMEA, MSA, Control Plan, and SPC techniques. * Awareness of lean manufacturing techniques. * Due to ITAR compliance, this position requires candidates to be a U.S. Citizen, Permanent Resident Alien, or Protected Individual per 8 U.S.C. 1324b(a)(3). Skills & Other Requirements * Expert Knowledge of the ISO 9001 criteria. * Awareness and understanding of the IATF 16949 criteria. * Process characterization and control techniques. * Able to balance financial and quality objectives. * Statistical expertise including FMEA, SPC, DOE, MSA, Process Capability. * Able to understand AIAG process control plans. * Able to facilitate cross-functional Kaizen Events. * Solve complex problems using intuition, induction, deduction, analysis of data, and advanced quality tools, and structured problem-solving methods. * Effectively work in cultures throughout North America, Europe, and Asia. * Able to think critically and to reengineer all elements of an Automotive Quality System to remove waste of time and dollars, while increasing Quality performance. * Willing to take intelligent risks to gain opportunities for quality innovation. * Excellent interpersonal, communication and presentation skills and ability to comprehend and communicate at a high level with executives, senior managers, and global customers, suppliers, and principals at different sites. * Able to relate well and work collaboratively with all levels within a site, from senior leaders to production operators. * Ability to deal effectively with differences of opinion, to influence, to draw ideas from others, and to negotiate and mediate. * Ability to anticipate and handle multiple priorities and complex/abstract issues involving external and internal priorities. * Ability to excel in a cross-organizational, cross-cultural, global team environment and to easily adjust in the face of challenge and change. * Handle special assignments promptly and professionally. * Maintain a high standard of ethics, professionalism, leadership, and competency. * Proven ability to lead and motivate people. * Demonstrates and promotes the Coherent ICARE Worldwide Values. * Knowledgeable in worldwide ESG norms. Working Conditions * Office Environment * Manufacturing Plant Environment, on occasion Physical Requirements * Ability to work at computer Safety Requirements All employees are required to attend scheduled training, follow the site EHS procedures and Coherent Corporate EHS standards. This includes the use of proper protective equipment (PPE) as required by the job responsibilities. Managers will ensure that all safety and environmental procedures are followed consistently. They will ensure that risk assessments are performed, proper training, work instructions, required PPE is available, and will monitor compliance. Quality & Environmental Responsibilities Depending on location, this position may be responsible for the execution and maintenance of the ISO 9000, 9001, 14001 and/or other applicable standards that may apply to the relevant roles and responsibilities within the Quality Management System and Environmental Management System. Culture Commitment Ensure adherence to company's values (ICARE) in all aspects of your position at Coherent: Integrity - Create an Environment of Trust Collaboration - Innovate Through the Sharing of Ideas Accountability - Own the Process and the Outcome Respect - Recognize the Value in Everyone Enthusiasm - Find a Sense of Purpose in Work

Dometic is a global market leader in the mobile living industry. Millions of people around the world use Dometic products in outdoor, residential, and professional applications. Our Marine organization is a trusted provider of innovative solutions for the worldwide boating and boat building industry, and we recently expanded our scope to lead the boating industry into an electrified future. Dometic has won numerous NMMA Innovation Awards over the years and we are always striving for new ways to make boating easier, safer, and more enjoyable. We are a journey of continuous growth - now looking for our next star - a passionate Quality Manager. This position reports to the General Manager and will work in Limerick, PA Dometic Marine's facility in Limerick, PA develops and manufactures mechanical steering control systems along with shift and throttle cables. As a Quality Manager in the Limerick, PA team, you will be involved in managing the overall quality control for manufactured products and compliance with the quality management system. Your main responsibilities Promote quality achievement and performance improvement across the organization. Lead and organize formal/informal problem solving in areas of scrap, process capability, warranty, etc., using; 8D, Shanin Red X, 3L5W and A3 reporting formats as examples. Develop and measure quality goals, KPI's and targets in the global and local organization's strategic plan. Establishes and implements metrics (process capability, control charts, measurement quality) for monitoring system effectiveness and to enable managers to make sound product quality decisions. Assess product specifications and customer requirements. Ensure compliance with national and international standards. Partner with engineering, manufacturing and purchasing to formulate and agree on comprehensive quality procedures. Liaise with other managers and staff, particularly in areas such as design, production and purchasing. Work closely with purchasing employees to establish supplier quality performance criteria and monitor supplier performance. Assess suppliers' product specifications and quality plans. Define processes and procedures in conjunction with operating employees. Supervise internal auditing and continual improvement to product or services. Work methodically to establish a clearly defined quality management system. Lead and coach technical employees in carrying out tests/checks, in a laboratory environment. Ensure tests and procedures are properly understood, carried out, evaluated and that product modifications are investigated if necessary. Act as key contact with customers' auditors and being responsible for ensuring the execution of corrective actions and ongoing compliance with customers' specifications. Write technical and management system reports that predict trends that will affect improvement of quality. Pinpoint relevant quality-related training needs. Consider application of environmental and health and safety standards. Customer and Executive level presentation experience is paramount. Complete additional job duties and assignments. What do we offer? You are offered an interesting role in a dynamic, fast paced and global environment with great opportunities to grow and take on new challenges. The growth at Dometic is continuous - which gives you great possibilities to evolve with the company. Medical/Dental/Vision Insurance Employee Assistance Program (EAP) Disability insurance (STD/LTD) 401 (k) with company match PTO Company defined holidays and two floating holidays for you to use as you choose Paid maternity/paternity leave Tuition assistance Membership reimbursement (wholesale club and gym) Employee discounts on our incredible products Opportunities to make an impact

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Quality Job Sub Function: Supplier Quality Job Category: People Leader All Job Posting Locations: Cornelia, Georgia, United States of America, Guaynabo, Puerto Rico, United States of America, Raritan, New Jersey, United States of America, San Angelo, Texas, United States of America Job Description: About MedTech Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech We are searching for the best talent for a Senior Manager Source Quality to be located in Guaynabo, PR, Cornelia, GA, San Angelo, TX and/or Raritan, NJ. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): Brazil and Mexico - Requisition Number: R-053884 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. The Senior Manager Source Quality manages a group of Source Quality professionals responsible for ensuring that ETHICON Suppliers provide purchased finished goods, direct and indirect materials or services that comply with Ethicon, J&J, Global Regulations, and industry standards. Using a risk-based approach, manages the Purchasing Control Process and lead the Source Quality Management and control program for ETHICON driving continuous process improvements and ensuring sustainable compliance with Ethicon, J&J, Global Regulations, and industry standards. You will be responsible for: Manage a significant, global supplier base consisting of suppliers of Purchased Finished Goods, Direct Materials /components and Indirect Materials & Services that impact the quality of products and/or the Quality System for ETHICON. Provide people leadership to a group of Source Quality professionals focused on developing people, both technical and people-based skills, and ensuring that those competencies match both the quality and business needs. Promotes diversity. Accountable for ensuring goals and objectives are met. Holds self and people accountable for results achieved through Credo Values and Leadership Imperatives. Removes barriers to people development. Models and fosters people development. Actively champions and supports people development to expand their capabilities, skills, knowledge and enable movement of talent. Drive development of both supplier base and supplier-focused initiatives within the ETHICON Franchise in support of robust, compliant products that continuously meet the needs of patients, customers, and business objectives. Identify, sponsor and champion Purchasing Control projects and programs ensuring the continuity of product supply as well as applicable Global Regulations and standards. Partner with Procurement, Manufacturing and R&D to manage and mitigate supplier risk across the product lifecycle. Ensure appropriate resource and budget and allocation decisions are made. Takes a leadership role in engaging key stakeholders to scope projects, resources, budgets, and timelines to ensure execution. Utilize analytical and problem-solving skills to develop and optimize supplier performance working in conjunction with the Enterprise SQM and Procurement Organizations. Develop and utilize Leading Indicators to ensure timely identification of risk/business challenges and opportunities. Analyzes quality system trends, identifies issues and seeks appropriate action. Leads a portfolio of projects through to support external supply quality systems initiatives. Interacts with stakeholders and sponsors to communicate project status and alignment with business objectives. Participates in the external supply selection process to provide quality system expertise. Ensures compliance to applicable Global Regulations and standards (e.g. QSR, ISO, EN, and Medical Device Directive (MDD) requirements). Serves as Purchasing Controls SME in internal and external audits. On behalf of the Director of Source Quality represents the company in contract negotiation and Quality Agreements with external manufacturers and suppliers. Escalate patient-safety and compliance risks appropriately. Comply with all environmental, safety and occupational health policies. (i.e., ISO14001 & OSHAS18001) Responsible for communicating business related issues or opportunities to next management level. Qualifications / Requirements: A minimum of a bachelor's degree in engineering, an Applied Science or a related technical and quality field is required. A master's degree is preferred. A minimum of 8+ years of experience in a regulated industry like Medical Devices, Pharma and/or Consumer is required. Experience in Quality Systems, Purchasing Control and/or Supplier Management is preferred. Broad experience with quality systems, including but not limited to qualification, validation, issue investigation, non-conformance, CAPA systems and investigations, laboratory controls, production, and process controls, is required. Experience with documentation and technical writing skills, in a regulated compliance environment, is required. Prior experience with Regulatory/FDA inspections is desirable. A minimum of 4 years of managerial experience is required. Hands-on experience in strategy development and deployment experience preferred. Computer literacy in the use of business software applications including Microsoft Office (Word, Excel, PowerPoint) is required. Working knowledge of regulatory compliance requirements (QSR, MDD, ISO 9001, ISO13485, ISO 14971 and other international standards). Working knowledge of issue investigations, Non-Conformance Reports (NCRs), Corrective and Preventative Actions (CAPAs) and Internal/External Audits is preferred. Demonstrated strong business acumen, organizational, and leadership skills required Excellent verbal and written communications skills required. ASQ Certified Quality Engineer (CQE), Manager of Quality/Organizational Excellence (CMQ/OE), Supplier Quality Professional (CSQP) preferred. ASQ Certified Quality Auditor (CQA) or Biomedical Auditor (CBA) preferred. Flawless Project Execution (FPX) or Project Management Professional (PMP) trained and certified preferred. Six Sigma Black Belt/ Green Belt (CSSBB)/CSSGB) or Lean certification from a recognized program or PE leadership training preferred. Fluent English mandatory; Spanish, Portuguese or German desired. Ability to collaborate with all levels of management in cross-functional team environment is required. This position may require up to 35% domestic and international travel. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills:

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Quality Job Sub Function: Supplier Quality Job Category: People Leader All Job Posting Locations: Cornelia, Georgia, United States of America, Guaynabo, Puerto Rico, United States of America, Raritan, New Jersey, United States of America, San Angelo, Texas, United States of America Job Description: About MedTech Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech We are searching for the best talent for a Senior Manager Source Quality to be located in Guaynabo, PR, Cornelia, GA, San Angelo, TX and/or Raritan, NJ. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): Brazil and Mexico - Requisition Number: R-053884 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. The Senior Manager Source Quality manages a group of Source Quality professionals responsible for ensuring that ETHICON Suppliers provide purchased finished goods, direct and indirect materials or services that comply with Ethicon, J&J, Global Regulations, and industry standards. Using a risk-based approach, manages the Purchasing Control Process and lead the Source Quality Management and control program for ETHICON driving continuous process improvements and ensuring sustainable compliance with Ethicon, J&J, Global Regulations, and industry standards. You will be responsible for: Manage a significant, global supplier base consisting of suppliers of Purchased Finished Goods, Direct Materials /components and Indirect Materials & Services that impact the quality of products and/or the Quality System for ETHICON. Provide people leadership to a group of Source Quality professionals focused on developing people, both technical and people-based skills, and ensuring that those competencies match both the quality and business needs. Promotes diversity. Accountable for ensuring goals and objectives are met. Holds self and people accountable for results achieved through Credo Values and Leadership Imperatives. Removes barriers to people development. Models and fosters people development. Actively champions and supports people development to expand their capabilities, skills, knowledge and enable movement of talent. Drive development of both supplier base and supplier-focused initiatives within the ETHICON Franchise in support of robust, compliant products that continuously meet the needs of patients, customers, and business objectives. Identify, sponsor and champion Purchasing Control projects and programs ensuring the continuity of product supply as well as applicable Global Regulations and standards. Partner with Procurement, Manufacturing and R&D to manage and mitigate supplier risk across the product lifecycle. Ensure appropriate resource and budget and allocation decisions are made. Takes a leadership role in engaging key stakeholders to scope projects, resources, budgets, and timelines to ensure execution. Utilize analytical and problem-solving skills to develop and optimize supplier performance working in conjunction with the Enterprise SQM and Procurement Organizations. Develop and utilize Leading Indicators to ensure timely identification of risk/business challenges and opportunities. Analyzes quality system trends, identifies issues and seeks appropriate action. Leads a portfolio of projects through to support external supply quality systems initiatives. Interacts with stakeholders and sponsors to communicate project status and alignment with business objectives. Participates in the external supply selection process to provide quality system expertise. Ensures compliance to applicable Global Regulations and standards (e.g. QSR, ISO, EN, and Medical Device Directive (MDD) requirements). Serves as Purchasing Controls SME in internal and external audits. On behalf of the Director of Source Quality represents the company in contract negotiation and Quality Agreements with external manufacturers and suppliers. Escalate patient-safety and compliance risks appropriately. Comply with all environmental, safety and occupational health policies. (i.e., ISO14001 & OSHAS18001) Responsible for communicating business related issues or opportunities to next management level. Qualifications / Requirements: A minimum of a bachelor's degree in engineering, an Applied Science or a related technical and quality field is required. A master's degree is preferred. A minimum of 8+ years of experience in a regulated industry like Medical Devices, Pharma and/or Consumer is required. Experience in Quality Systems, Purchasing Control and/or Supplier Management is preferred. Broad experience with quality systems, including but not limited to qualification, validation, issue investigation, non-conformance, CAPA systems and investigations, laboratory controls, production, and process controls, is required. Experience with documentation and technical writing skills, in a regulated compliance environment, is required. Prior experience with Regulatory/FDA inspections is desirable. A minimum of 4 years of managerial experience is required. Hands-on experience in strategy development and deployment experience preferred. Computer literacy in the use of business software applications including Microsoft Office (Word, Excel, PowerPoint) is required. Working knowledge of regulatory compliance requirements (QSR, MDD, ISO 9001, ISO13485, ISO 14971 and other international standards). Working knowledge of issue investigations, Non-Conformance Reports (NCRs), Corrective and Preventative Actions (CAPAs) and Internal/External Audits is preferred. Demonstrated strong business acumen, organizational, and leadership skills required Excellent verbal and written communications skills required. ASQ Certified Quality Engineer (CQE), Manager of Quality/Organizational Excellence (CMQ/OE), Supplier Quality Professional (CSQP) preferred. ASQ Certified Quality Auditor (CQA) or Biomedical Auditor (CBA) preferred. Flawless Project Execution (FPX) or Project Management Professional (PMP) trained and certified preferred. Six Sigma Black Belt/ Green Belt (CSSBB)/CSSGB) or Lean certification from a recognized program or PE leadership training preferred. Fluent English mandatory; Spanish, Portuguese or German desired. Ability to collaborate with all levels of management in cross-functional team environment is required. This position may require up to 35% domestic and international travel. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills:

Line of Business: Cement & White About Us Heidelberg Materials is one of the world's largest suppliers of building materials. Heidelberg Materials North America operates over 450 locations across the U.S. and Canada with approximately 9,000 employees. What You'll Be Doing Lead and implement quality control programs to ensure product compliance with internal and external standards Monitor production processes and conduct audits to identify areas for improvement Collaborate with operations and technical teams to resolve quality issues and drive continuous improvement Train and support plant personnel on quality procedures and best practices Analyze data and prepare reports to communicate quality performance and trends What Are We Looking For Demonstrated ability to lead quality initiatives in a manufacturing or industrial environment Bachelor's degree or equivalent experience in Chemistry, Chemical Engineering, or related field Strong analytical and problem-solving skills with a focus on continuous improvement Effective communication and collaboration across cross-functional teams Proficiency in quality systems, standards, and tools (e.g., ISO, Six Sigma, SPC) Capability to manage multiple priorities and adapt to changing business needs Work Environment This role operates in a plant environment with exposure to industrial equipment, materials, and processes. Occasional travel to other facilities may be required. What We Offer Competitive base salary ($95,330 - $119,160) and participation in our annual incentive plan 401(k) retirement savings plan with an automatic company contribution as well as matching contributions Highly competitive benefits programs, including: Medical, Dental, and Vision along with Prescription Drug Benefits Health Saving Savings Account (HSA), Health Reimbursement Account (HRA) and Flexible Spending Account (FSA) AD&D, Short- and Long-Term Disability Coverage as well as Basic Life Insurance Paid Bonding Leave, 15 days of Paid Vacation, 40 hours of Paid Sick Leave and 10 Paid Holidays Equal Opportunity Employer - Minority / Female / Veteran / Disabled

Job Description: Quality Assurance and Training Manager Element Risk Management 's Core Values: Proactive Stewardship. We manage and protect the relationships and resources entrusted to us with the utmost care. Confident Humility. We approach our work with self-assurance and expertise, while remaining open to learning and valuing the insights of others. Unshakable Integrity. We commit to honesty, transparency, and doing what is right even when faced with adversity or no one is watching. Continuous Improvement. We seek opportunities to enhance our skills, processes, and services while fostering a spirit of excellence, innovation, and growth. Relentless Perseverance. We embrace challenges with tenacity, discipline, and endurance. Position Overview: This role is pivotal in ensuring our products/services meet the highest standards of quality, compliance, and customer satisfaction. The ideal candidate will play a key role in driving continuous improvement initiatives, support employee training, leveraging technology to optimize processes, and leading internal audits to maintain operational excellence. This position demands a blend of technical experience, leadership skills and a keen eye for detail to maintain standards of quality and customer satisfaction. KEY RESPONSIBILITIES AND DUTIES: At all times, the Quality Assurance and Training Manager shall: Quality Oversight & Compliance Works with department managers to develop QA procedures and standards Ensure compliance with agency standards and process adherence, through internal audits Assist in the reporting of key quality metrics and KPIs Training & Development Quarterback training programs across Small Business and Personal Lines teams to enhance quality awareness and best practices for new and existing employees Manages and trains VAs (virtual assistants) Responsibility in identifying areas for process improvement and quality issues, recommends solutions in support of a culture of continuous improvement Lead cross-functional initiatives to improve operational efficiency, reduce errors, and enhance product/service quality. Evaluates SOPs Internal Audits & Risk Management Assists with planning and developing internal audits Coordinate with relevant teams to address audit findings JOB REQUIREMENTS and QUALIFICATIONS: College degree or equivalent is desired. Must be organized with demonstrated skills for effective communication both verbal and written with the ability to influence others. Should be familiar with all operations with a thorough understanding of the agency system. OTHER RELEVANT REMARKS: This position description describes the general nature and level of work performed. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this position. This position description is not intended as and does not create a contract of employment between the Agency and any individual employee. The Agency reserves the right to change this position description at any time within its sole discretion.

Benefits: 401(k) 401(k) matching Competitive salary Dental insurance Employee discounts Health insurance Opportunity for advancement Paid time off Training & development Vision insurance Wellness resources LEHIGH VALLEY ADULT SERVICES JOB DESCRIPTION Job Title: Quality Management Coordinator FLSA STATUS: Non-exempt SUMMARY The Quality Management Coordinator of Lehigh Valley Adult Services will be responsible for creating and enforcing a Quality Assurance System for evaluating performance that focuses on structure, processes, and outcomes to reduce or resolve identified problems or implement process improvements. Quality Assurance Programs are to be planned, objective, comprehensive, systematic, measurable, and ongoing. There should be a system of checks and balances for the company through the development of standards with measurable goals, documentation of policies and procedures, staff training, and review of data associated with standards. The Quality Management Coordinator will confirm and enforce adherence to standards and Federal, State, and Statute laws and Regulation. This will also include monitoring activities to assure or improve the quality of care and services. ESSENTIAL DUTIES AND RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO: Investigate incidents and manage EIM within HCSIS. Identify areas in need of improvement and implement process improvements. Develop corrective actions to address areas of deficiencies. Follow up monitoring to ensure effectiveness of corrective actions taken to rectify concern(s). Review findings with QA Committee members and staff involved in the review process, etc. Obtain necessary resources to implement corrective actions. Develop educational information, policies, procedures, etc. pertinent to corrective actions. Educate and train staff, residents, and families (as necessary) to the upcoming corrective actions (changes). There should be a periodic review of residential finance reports or medication records, or any other method for monitoring. Assign a monitoring time frame for each area and person responsible for follow up. Identify processes for the staff, supervisor, and director to review effectiveness of corrective action (s) and provide feedback on next steps. Provide a mechanism for communicating quality to appropriate parties including, but not limited to, administrative and executive staff, residents, family members and staff. Serve as a mechanism for communicating accomplishments to appropriate parties including, but not limited to, Board of Directors, administrative and executive staff, residents family members. Assign and conduct investigations Enter and finalize unusual incidents Conducting Satisfaction Surveys Adhere to HEDI Other duties as assigned. QUALIFICATIONS Successful completion of FBI fingerprint (as required), PA Criminal Background Check, Child Abuse Clearance, Drug Screen, and complete a Physical Working knowledge of EIM/EMC Excellent communication skills Analytical Skills A desire to help others achieve their best EDUCATION AND/OR EXPERIENCE Bachelors degree with experience in the field (Master Preferred) Experience in licensing Ability to analyze data and create and review processes Experience working with persons that have Intellectual Disabilities: 5 years (Preferred) Hours of Work / Compensation Fulltime, including possible nights and weekends Language Skills Ability to read and interpret documents such as procedure manuals and work instructions. Ability to write routine reports and correspondence. Ability to speak and communicate well with customers and staff. CERTIFICATES, LICENSES, REGISTRATIONS Must remain current and updated Must complete 48 hours of training Annually Certified Investigator preferred, or willing to obtain certification within the first three (3) months of employment. PHYSICALS DEMANDS The physical demands described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For the most part ambient room temperatures, lighting, and traditional office equipment as found in a typical office environment.

OVERALL RESPONSIBILITIES: Customer Quality member responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions. These activities include intake, investigation, documentation, follow-up, regulatory reporting and metrics. The Customer Quality Specialist is responsible for the oversight and direct support of technical evaluations and investigational tasks required for complaint processing/closure. The Customer Quality Specialist works collaboratively with Quality, Engineering, Manufacturing, Product Development and other functional experts. DUTIES: • Responsible and accountable for on-time submission and accuracy of regulatory reports • Review and complete determination associated Medical Device Report and/or Vigilance Report • Knowledge of and familiarity with global regulations for reporting • Directly interface with service centers, Hospitals, Surgeons, and Internal employees for reporting of complaints and adverse events • Interact positively with internal, external business partners and colleagues • Adhere and comply to work instructions, standard operating procedures, and regulations • Expedite investigations by collaborating with internal/external business partners • Achieve productivity targets • Fully trained within three months of hire • Achieve accuracy targets for complaint documentations • Participate in projects and events • Complaint determination • Reportability assessments • Conduct follow-ups with complainant, reporters • Checking your own work • Updating SharePoint • Tracking complaints in the process for closure • All other duties as assigned Qualifications • Bachelor's Degree or equivalent experience • Generally requires 2-4 years of related work experience • RAC or ASQ certifications a plus Additional Information All your information will be kept confidential according to EEO guidelines.

What we are looking for: The Quality Engineering Manager is responsible for the development, application, validation and maintenance of manufacturing and quality management systems associated with compliance to internal procedures, customer requirements and applicable regulatory standards for products and components. What you will do: Performs and documents timely Corrective and Preventive Actions (CAPA) investigations. Performs and documents customer complaint investigations, performs root cause analysis and develops corrective and preventive actions. Works with customers to provide required technical support and information regarding the investigation. Acts as lead on assigned CAPAs to drive corrective actions and closure of CAPA within prescribed timelines. Completes Supplier Corrective Action Requests (SCARs) and communicates with suppliers in regard to non-conformances, supplier changes, etc. Performs product support for product development and commercial products (reviews/approves product specifications, customer drawings, product validations protocols). Performs statistical data analysis utilizing statistical software (Minitab and Excel). Develops and implements statistical methods and designs experiments to support process control and process/product improvement. Performs physical and visual Test Method Validation/Gage R & R activities by developing and executing protocols for new or existing processes. Performs Risk Management activities utilizing risk management tools (pFMEAs (Process Failure Mode and Effect Analysis), etc.). Supports development and implementation of methods for sampling, inspection, testing and evaluation of products. Interfaces with customers to provide technical support for our products/complaints/change control. Reviews/approves applicable validation and qualification documents for compliance with internal procedures (Installation Qualification (IQ), Operational Qualification (OQ), RQP, Internal Product Development Process (IPDP) phase transfer documents, Document Control Revisions (DCRs), etc.) Supports customer and/or third-party audits as required. May be trained as an auditor and perform quality audits. Identifies staffing requirements, participates in the selection and hiring process; interviews applicants and makes hire recommendations. Provides coaching, feedback, and guidance to team members on a continual basis and takes an active role in developing, monitoring, and updating a career plan for advancement. Completes performance appraisals and reviews with employees; recommends salary increases to management and HR. Provides input to the department budgeting process and monitors and controls expenses through the year to meet budget requirements. Manages other Quality Engineers, to be able to participate in their development and performance reviews. Supports Strategic accounts as assigned and as needed Who you are: Bachelor's degree in one or more of the following - Life sciences Engineering, Engineering, Quality, Life sciences. 5-7 years- including co-op experience Minimum 3-5 years of direct managerial or supervisory experience, including hiring, coaching, performance management, and team development; proven ability to lead cross-functional teams and drive departmental goals. Experience in life sciences/GMP industry in one or more of the following functions: Quality Assurance, Quality Engineering, Validation, Product Development, Process Engineering or Manufacturing Engineering Knowledge of applicable regulatory standards, specifically ISO 13485 or possess the ability to understand and enforce the practices. Knowledge of FDA Regulation 21 CFR Part 820 preferred but not required Able to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community. Strong problem solving and analytical skills, with concentration on risk analysis. Demonstrated project organizational skills required Strong written and verbal communication skills. Ability to apply principles of scientific thinking to a wide range of intellectual and practical problems; deal with nonverbal symbolism (e.g., formulas, scientific equations, graphs); deal with a variety of abstract and concrete variables. Demonstrated ability to participate in and/or lead cross functional teams, ability to independently prioritize and execute projects and responsibilities. Intermediate to advanced knowledge of MS Office Suite and statistical software (e.g., Minitab). Knowledge of statistics, design of experiments, sampling, gauge R&R, FMEA/risk management, and process control. Excellent customer service focus and professionalism. Strong Supervisory skills. What we offer: Annual Bonuses Health Insurance: Medical with Rx plan / Dental / Vision 401k (retirement savings) with excellent company match Company Paid Short-Term and Long-Term Disability Generous Paid Time off and Holiday Pay

What we are looking for: The Quality Engineering Manager is responsible for the development, application, validation and maintenance of manufacturing and quality management systems associated with compliance to internal procedures, customer requirements and applicable regulatory standards for products and components. What you will do: Performs and documents timely Corrective and Preventive Actions (CAPA) investigations. Performs and documents customer complaint investigations, performs root cause analysis and develops corrective and preventive actions. Works with customers to provide required technical support and information regarding the investigation. Acts as lead on assigned CAPAs to drive corrective actions and closure of CAPA within prescribed timelines. Completes Supplier Corrective Action Requests (SCARs) and communicates with suppliers in regard to non-conformances, supplier changes, etc. Performs product support for product development and commercial products (reviews/approves product specifications, customer drawings, product validations protocols). Performs statistical data analysis utilizing statistical software (Minitab and Excel). Develops and implements statistical methods and designs experiments to support process control and process/product improvement. Performs physical and visual Test Method Validation/Gage R & R activities by developing and executing protocols for new or existing processes. Performs Risk Management activities utilizing risk management tools (pFMEAs (Process Failure Mode and Effect Analysis), etc.). Supports development and implementation of methods for sampling, inspection, testing and evaluation of products. Interfaces with customers to provide technical support for our products/complaints/change control. Reviews/approves applicable validation and qualification documents for compliance with internal procedures (Installation Qualification (IQ), Operational Qualification (OQ), RQP, Internal Product Development Process (IPDP) phase transfer documents, Document Control Revisions (DCRs), etc.) Supports customer and/or third-party audits as required. May be trained as an auditor and perform quality audits. Identifies staffing requirements, participates in the selection and hiring process; interviews applicants and makes hire recommendations. Provides coaching, feedback, and guidance to team members on a continual basis and takes an active role in developing, monitoring, and updating a career plan for advancement. Completes performance appraisals and reviews with employees; recommends salary increases to management and HR. Provides input to the department budgeting process and monitors and controls expenses through the year to meet budget requirements. Manages other Quality Engineers, to be able to participate in their development and performance reviews. Supports Strategic accounts as assigned and as needed Who you are: Bachelor's degree in one or more of the following - Life sciences Engineering, Engineering, Quality, Life sciences. 5-7 years- including co-op experience Minimum 3-5 years of direct managerial or supervisory experience, including hiring, coaching, performance management, and team development; proven ability to lead cross-functional teams and drive departmental goals. Experience in life sciences/GMP industry in one or more of the following functions: Quality Assurance, Quality Engineering, Validation, Product Development, Process Engineering or Manufacturing Engineering Knowledge of applicable regulatory standards, specifically ISO 13485 or possess the ability to understand and enforce the practices. Knowledge of FDA Regulation 21 CFR Part 820 preferred but not required Able to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community. Strong problem solving and analytical skills, with concentration on risk analysis. Demonstrated project organizational skills required Strong written and verbal communication skills. Ability to apply principles of scientific thinking to a wide range of intellectual and practical problems; deal with nonverbal symbolism (e.g., formulas, scientific equations, graphs); deal with a variety of abstract and concrete variables. Demonstrated ability to participate in and/or lead cross functional teams, ability to independently prioritize and execute projects and responsibilities. Intermediate to advanced knowledge of MS Office Suite and statistical software (e.g., Minitab). Knowledge of statistics, design of experiments, sampling, gauge R&R, FMEA/risk management, and process control. Excellent customer service focus and professionalism. Strong Supervisory skills. What we offer: Annual Bonuses Health Insurance: Medical with Rx plan / Dental / Vision 401k (retirement savings) with excellent company match Company Paid Short-Term and Long-Term Disability Generous Paid Time off and Holiday Pay

NOW HIRING: QUALITY COORDINATOR Monday-Friday | 8:00AM-4:30PM On-site in Douglassville PA Job Title: Quality Coordinator Department: Quality Schedule: 1st Shift - Monday-Friday 8:00AM-4:30PM Exciting opportunity to be part of a high-performing team that values precision, efficiency, and collaboration! Are you detail-oriented, highly organized, and ready to make an impact in both quality assurance and legal support? Do you thrive in a fast-paced environment where collaboration and problem-solving are essential? If so, American Crane & Equipment Corporation (ACECO) is looking for a Quality Coordinator to join our high-performing team! Why Join Us? (Check us out on YouTube here) Build transferable experience across Quality and Compliance functions to support long-term career growth Gain exposure to NQA-1 processes, quality documentation, legal support, and compliance coordination in a regulated manufacturing environment Work in a role where accuracy, organization, and follow-through truly matter Partner closely with leaders across Quality, Legal, Finance, Sales, and Operations Join a people-first organization that values growth, accountability, and doing the right thing Build a long-term career with a company known for stability, low turnover, and internal development What You'll Do: Quality Assurance & Administrative Support Assist with reviewing Quality documentation for incoming shipments Help create and modify procedures as needed Organize and maintain electronic QA records and documentation Provide alternate support for document control processes Bid List & Sales Qualifications Management Respond to bid list and qualification requests within 24 hours Keep bid list registrations up to date and manage relevant credentials Monitor bid-related email inboxes and maintain a library of necessary information Support the completion of registrations and certifications Process & Project Coordination Coordinate and support scanning and administrative activities related to quality documentation What We're Looking For: Education & Training High school diploma or equivalent required Associate's degree or coursework in Business Administration, Quality, Compliance, or a related field preferred Willingness to learn internal systems, procedures, and regulatory requirements Experience 2+ years of administrative or coordination experience in a corporate, quality, legal, compliance, or regulated environment Experience working with confidential or sensitive information preferred Experience supporting multiple departments, or projects simultaneously Prior exposure to documentation management, recordkeeping, compliance support, or process coordination preferred Skills & Attributes Strong organizational skills with high attention to detail Ability to manage sensitive and confidential information with discretion and integrity Proficient in Microsoft Office (Excel, Word, Outlook, Teams) Comfortable tracking, maintaining, and organizing electronic records and documentation Clear, professional written and verbal communication skills Ability to prioritize tasks, meet deadlines, and adapt to changing priorities Self-directed, dependable, and comfortable working independently as well as collaboratively Alignment with ACECO's values: Work Hard, Have Fun, and Do the Right Thing REQUIREMENTS Authorization to work in the United States without current or future employer sponsorship Ability to verify identity and employment authorization (Form I-9) Eligibility to access information or technology governed by U.S. export control laws (including 10 C.F.R. Part 810, EAR, and/or ITAR), where applicable Willingness to undergo a background check in accordance with applicable laws Willingness to undergo a pre-employment drug screen in accordance with company policy and randomize drug screens during employment Ability to meet the posted work schedule and work required hours Ability to maintain reliable attendance and punctuality Willingness to follow all company safety policies and procedures Willingness to wear appropriate PPE when in or around the shop areas Willingness to complete required safety and compliance trainings Ability to perform the essential functions of the position, with or without reasonable accommodation Ability to maintain professional conduct aligned with company values and expectations ADDITION REQUIREMENTS FOR THE POSITION Ability to work full-time, on-site Monday-Friday, 8:00AM-4:30PM or schedule approved by manager Ability to maintain strict confidentiality when handling sensitive legal, quality, and compliance information Proficiency in Microsoft Office (Excel, Word, Outlook) and ability to learn internal systems and software Ability to effectively manage multiple priorities and meet time-sensitive deadlines Eligibility to access information or technology governed by U.S. export control laws, including 10 C.F.R. Part 810. If government authorization is required for access to controlled technology, employment or start date may be delayed or withdrawn in accordance with applicable law Certain positions and projects may require the ability to obtain and maintain unescorted access to nuclear facilities in compliance with NRC regulations (10 C.F.R. Parts 26 & 73) Ability to occasional lift office materials (files, boxes etc) up to 25 lbs Ability to sit for extended periods and work at a computer for most of the workday Work requires sustained attention to detail, organization, and accuracy Work Environment: Primarily an office-based, on-site role in a professional corporate environment Regular collaboration with Quality, Finance, Sales, and Operations teams Frequent use of computers, document management systems, and standard office equipment Occasional interaction with manufacturing and shop-floor personnel to support documentation and process needs Fast-paced environment with multiple priorities, deadlines, and time-sensitive requests What's In It For You? At American Crane & Equipment Corporation, we invest in people who want to do meaningful work, grow their skills, and build a long-term career. The Foundation Competitive salary based on experience, skills, education, and market data Comprehensive medical, vision, dental, and life insurance available day one Generous paid time off with rollover each year 401(k) retirement plan with company match 10 paid company-observed holidays Tuition reimbursement and professional development opportunities Role-Specific Highlights - Quality Coordinator High-Visibility Role - Directly support Quality, Compliance, and Operations in a regulated manufacturing environment Transferable Career Experience - Gain exposure to processes, documentation control, audits, and compliance coordination Predictable Schedule - Consistent first-shift, weekday hours in a professional office environment Impact Without Shift Work - Play a critical role in quality outcomes without shop-floor or rotating shifts Long-Term Stability - Join a company known for low turnover, strong processes, and internal development APPLY TODAY for an Exciting Career Opportunity! How to Apply: Submit your application online at Recruitment (adp.com). All offers of employment are contingent upon the successful completion of a background check and drug screen, subject to applicable laws and regulations. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. American Crane & Equipment Corporation is an Equal Opportunity Employer. The company maintains and observes employment policies that do not discriminate against any person because of race, color, sex, sexual orientation, gender identity, national origin, religion, disability, age, ancestry and any other basis prohibited by federal, state or local law. This applies to recruiting, hiring, training, compensation, overtime, job classifications, work assignments, promotions, demotions, layoffs, terminations, transfers, and all other conditions of employment. The pay for this position is dependent on circumstances including an applicant's skills and qualifications, certain degrees and certifications, prior job experience, market data, and other relevant factors. American Crane & Equipment Corporation offers a wide array of comprehensive benefit programs and services including medical, dental, vision, flexible spending and health savings accounts to our benefits-eligible employees. Additional benefits include retirement savings plans like 401(k) and paid time off, paid holidays, and disability coverage. Some benefits offerings are subject to any legal requirements or limitations, employee eligibility status, and where the employee lives and/or works. NOTE: American Crane & Equipment Corporation is not seeking assistance or accepting unsolicited resumes from search firms for employment opportunities, unless they have a written agreement for the position they are contacting us about. Regardless of past practice, all resumes submitted by search firms to any employee at American Crane & Equipment Corporation without a valid written search agreement in place for that position will be deemed the sole property of American Crane & Equipment Corporation, and no fee will be paid in the event the candidate is hired by American Crane & Equipment Corporation as a result of the referral or through other means.

NOW HIRING: QUALITY COORDINATOR Monday-Friday | 8:00AM-4:30PM On-site in Douglassville PA Job Title: Quality Coordinator Department: Quality Schedule: 1st Shift - Monday-Friday 8:00AM-4:30PM Exciting opportunity to be part of a high-performing team that values precision, efficiency, and collaboration! Are you detail-oriented, highly organized, and ready to make an impact in both quality assurance and legal support? Do you thrive in a fast-paced environment where collaboration and problem-solving are essential? If so, American Crane & Equipment Corporation (ACECO) is looking for a Quality Coordinator to join our high-performing team! Why Join Us? (Check us out on YouTube here) Build transferable experience across Quality and Compliance functions to support long-term career growth Gain exposure to NQA-1 processes, quality documentation, legal support, and compliance coordination in a regulated manufacturing environment Work in a role where accuracy, organization, and follow-through truly matter Partner closely with leaders across Quality, Legal, Finance, Sales, and Operations Join a people-first organization that values growth, accountability, and doing the right thing Build a long-term career with a company known for stability, low turnover, and internal development What You'll Do: Quality Assurance & Administrative Support Assist with reviewing Quality documentation for incoming shipments Help create and modify procedures as needed Organize and maintain electronic QA records and documentation Provide alternate support for document control processes Bid List & Sales Qualifications Management Respond to bid list and qualification requests within 24 hours Keep bid list registrations up to date and manage relevant credentials Monitor bid-related email inboxes and maintain a library of necessary information Support the completion of registrations and certifications Process & Project Coordination Coordinate and support scanning and administrative activities related to quality documentation What We're Looking For: Education & Training High school diploma or equivalent required Associate's degree or coursework in Business Administration, Quality, Compliance, or a related field preferred Willingness to learn internal systems, procedures, and regulatory requirements Experience 2+ years of administrative or coordination experience in a corporate, quality, legal, compliance, or regulated environment Experience working with confidential or sensitive information preferred Experience supporting multiple departments, or projects simultaneously Prior exposure to documentation management, recordkeeping, compliance support, or process coordination preferred Skills & Attributes Strong organizational skills with high attention to detail Ability to manage sensitive and confidential information with discretion and integrity Proficient in Microsoft Office (Excel, Word, Outlook, Teams) Comfortable tracking, maintaining, and organizing electronic records and documentation Clear, professional written and verbal communication skills Ability to prioritize tasks, meet deadlines, and adapt to changing priorities Self-directed, dependable, and comfortable working independently as well as collaboratively Alignment with ACECO's values: Work Hard, Have Fun, and Do the Right Thing Requirements Valid proof of identity and authorization to work in the U.S. (Form I-9) Eligibility to access information or technology governed by U.S. export control laws, including 10 C.F.R. Part 810. If government authorization is required for access to controlled technology, employment or start date may be delayed or withdrawn in accordance with applicable law Certain positions and projects may require the ability to obtain and maintain unescorted access to nuclear facilities in compliance with NRC regulations (10 C.F.R. Parts 26 & 73) Ability to maintain strict confidentiality when handling sensitive legal, quality, and compliance information Work Environment: Primarily an office-based, on-site role in a professional corporate environment Regular collaboration with Quality, Finance, Sales, and Operations teams Frequent use of computers, document management systems, and standard office equipment Work requires sustained attention to detail, organization, and accuracy Occasional interaction with manufacturing and shop-floor personnel to support documentation and process needs Fast-paced environment with multiple priorities, deadlines, and time-sensitive requests Ability to sit for extended periods and work at a computer for most of the workday Occasional lifting of office materials (files, boxes) up to 25 lbs What's In It For You? Become a Full-time employee and receive the following: Competitive salary based on experience, skills, education, market data, etc Comprehensive medical, vision, dental, and life insurance - DAY 1 (NO WAIT) Wellness plan Tuition reimbursement Generous paid time off hours that can accumulate over time 401K retirement plan with up to a 3% company match 10 Paid Company Observed Holidays Overtime opportunities & more! APPLY TODAY for an Exciting Career Opportunity! How to Apply: Submit your application online at Recruitment (adp.com). All offers of employment are contingent upon the successful completion of a background check and drug screen, subject to applicable laws and regulations. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. American Crane & Equipment Corporation is an Equal Opportunity Employer. The company maintains and observes employment policies that do not discriminate against any person because of race, color, sex, sexual orientation, gender identity, national origin, religion, disability, age, ancestry and any other basis prohibited by federal, state or local law. This applies to recruiting, hiring, training, compensation, overtime, job classifications, work assignments, promotions, demotions, layoffs, terminations, transfers, and all other conditions of employment. The pay for this position is dependent on circumstances including an applicant's skills and qualifications, certain degrees and certifications, prior job experience, market data, and other relevant factors. American Crane & Equipment Corporation offers a wide array of comprehensive benefit programs and services including medical, dental, vision, flexible spending and health savings accounts to our benefits-eligible employees. Additional benefits include retirement savings plans like 401(k) and paid time off, paid holidays, and disability coverage. Some benefits offerings are subject to any legal requirements or limitations, employee eligibility status, and where the employee lives and/or works. NOTE: American Crane & Equipment Corporation is not seeking assistance or accepting unsolicited resumes from search firms for employment opportunities, unless they have a written agreement for the position they are contacting us about. Regardless of past practice, all resumes submitted by search firms to any employee at American Crane & Equipment Corporation without a valid written search agreement in place for that position will be deemed the sole property of American Crane & Equipment Corporation, and no fee will be paid in the event the candidate is hired by American Crane & Equipment Corporation as a result of the referral or through other means.

OVERALL RESPONSIBILITIES: Customer Quality member responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions. These activities include intake, investigation, documentation, follow-up, regulatory reporting and metrics. The Customer Quality Specialist is responsible for the oversight and direct support of technical evaluations and investigational tasks required for complaint processing/closure. The Customer Quality Specialist works collaboratively with Quality, Engineering, Manufacturing, Product Development and other functional experts. DUTIES: • Responsible and accountable for on-time submission and accuracy of regulatory reports • Review and complete determination associated Medical Device Report and/or Vigilance Report • Knowledge of and familiarity with global regulations for reporting • Directly interface with service centers, Hospitals, Surgeons, and Internal employees for reporting of complaints and adverse events • Interact positively with internal, external business partners and colleagues • Adhere and comply to work instructions, standard operating procedures, and regulations • Expedite investigations by collaborating with internal/external business partners • Achieve productivity targets • Fully trained within three months of hire • Achieve accuracy targets for complaint documentations • Participate in projects and events • Complaint determination • Reportability assessments • Conduct follow-ups with complainant, reporters • Checking your own work • Updating SharePoint • Tracking complaints in the process for closure • All other duties as assigned Qualifications • Bachelor's Degree or equivalent experience • Generally requires 2-4 years of related work experience • RAC or ASQ certifications a plus Additional Information All your information will be kept confidential according to EEO guidelines.