Quality assurance manager jobs in Allentown, PA

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 Quality Assurance Manager- leads a team of quality professionals that provide quality oversight, GMP guidance and support and make quality related decisions for the designated functional areas within the Sharp Commercial sites. Responsibilities include but are not limited to the supervision of quality activities, assessment for new and ongoing projects, provide direction for cGMPs to direct reports and make recommendations on resolutions and/or path forward for quality related issues. The Quality Assurance Manager is responsible for ensuring all customers receive the appropriate level of quality support and partnership. The QA Manager and their team will work closely with customers on a routine basis and the QA Manager will serve as the first level of escalation for all 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 for the QA Manager. Other duties may also be assigned: Directly supervise the work activities of employees engaged in quality related tasks on the floor to ensure that products and processes meet customers, company, and regulatory requirements/standards. Participate in internal, regulatory and customer audits at the discretion of management. Review and investigate nonconformances and complaints as needed. Create, review and revise SOPs on a designated basis to ensure accuracy. Assist in appropriate problem-solving initiatives to address customer or regulatory quality issues as requested by senior management. Effectively communicate a variety of personnel actions, e.g., employment, termination, performance and salary reviews, disciplinary actions, scheduling and/or approving overtime. Represent Sharp Quality Operations as the main point of contact / SME for customer meetings and calls. Support training department to identify new opportunities for training program. Serve as the alternate for the Head of Quality during he/her absences. Summarize data, draw conclusions, and turn recommendations into clear communications to be distributed to all levels of the organization. Support the manufacturing team to ensure the compliance of processes and products and ensure testing and inspection meet all requirements. Track and monitor internal and customer KPIs related to quality control and implement programs designed to increase employee's awareness and knowledge of product nonconformities. Assure efficient and economical utilization of materials and continuous improvement of methods to eliminate wasteful practices within the department. Identify and implement quality system improvements when gaps are identified through audits, investigations, and departmental reviews. Responsible for training, development, motivating and counseling of subordinate staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies. Work with the team of training specialists to develop processes and best practices for building, managing, and continually improving GMP training program for new and existing staff according to cGMP's and in alignment with Sharp's Global Training Standard. 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 accommodation may be made to enable individuals with disabilities to perform the essential functions. SUPERVISORY RESPONSIBILITIES: Direct supervision of quality 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 five to seven years of related experience or Associate's degree with seven to ten years of related experience or a minimum of ten years' 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. Knowledge of statistical concepts, methods, and software (knowledge of Minitab is a plus). Strong data gathering and analytical skills using statistical software. Strong root cause analysis skills, and the ability to apply rigorous structured problem-solving techniques. 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 accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands to handle or write and to speak and hear. 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 accommodation 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 and routinely go onto the shop floor. The working environment is clean and not normally subject to hazardous environment or conditions. 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.

Job Description HoverTech International, a medical device company and leader in the safe patient and handling and movement is seeking a Director of Quality Assurance & Regulatory Affairs to join their team. This opportunity is in Allentown, PA, has one direct report and requires 10% international travel. The Director of Quality Assurance & Regulatory Affairs will lead the company's quality system and regulatory compliance activities. This role is responsible for ensuring that the Quality Management System meets FDA, ISO 13485, and global regulatory requirements, while also serving as the company's primary regulatory contact for the U.S., Canada, U.K., and EU. The ideal Director of Quality Assurance & Regulatory Affairs candidate has solid experience with Class II devices, understands global regulatory frameworks, and is comfortable in a hands-on leadership role in a growing organization. HoverTech International offers… Competitive compensation 100% employer paid benefits (for employee and family) Medical, dental, vision 401K plan Life insurance Tuition reimbursement Laid-back dress code and is dog friendly! The Director of Quality Assurance & Regulatory Affairs will be responsible for: Quality Assurance (QA) Maintain and continually improve the Quality Management System in compliance with FDA 21 CFR 820, ISO 13485, and applicable global standards. Oversee CAPA, complaint handling, non-conformances, internal audits, and supplier quality. Serve as the Supplier Quality Contact, managing supplier evaluations, audits, and ongoing performance monitoring. Lead document control, change control, training systems, and production quality processes. Oversee risk management activities in accordance with ISO 14971. Serve as the Management Representative during audits and inspections. Regulatory Affairs (RA) No 510(k) submissions required, but responsible for all ongoing global regulatory maintenance. Serve as the company's: FDA Registration Owner and primary FDA contact, US Agent for applicable products, EU PRRC (Person Responsible for Regulatory Compliance) for EUDAMED, Canada Regulatory Contact (e.g., MDEL maintenance) and UK Responsible Person / PRRC. Maintain device listings, establishment registrations, and regulatory documentation for all markets. Coordinate with distributors, authorized representatives, and regulatory bodies. Review and approve labeling, IFUs, marketing content, and product changes for regulatory compliance. Monitor regulatory changes and communicate impacts to leadership. Leadership Work closely with Engineering, Operations, and Executive Leadership to embed quality and regulatory requirements across the organization. Provide clear, practical regulatory guidance for sustaining products and new initiatives. Represent QA/RA during leadership meetings, audits, and customer visits. Director of Quality Assurance & Regulatory Affairs Qualifications: Bachelor's degree in engineering, science, quality, regulatory, or related field. 5-10+ years of regulatory and quality experience in medical devices. 5+ year's experience with a QMS (Greenlight Guru preferred). Strong understanding of Class I/ Class Il medical device requirements. Experience with FDA QSR, ISO 13485, and global regulatory frameworks. Experience managing establishment registrations and serving as a regulatory contact. Background in supplier quality, audits, and QMS compliance. Excellent organizational, documentation, and communication skills. Must be open to 10% international travel.

Oversees and manages the Quality Management System and Quality Program to ensure consistent production of products that meet established quality standards. Plans, coordinates, and directs quality initiatives, working both independently and through subordinates to maintain and improve product quality. Responsibilities Overall responsibility for the implementation, training and maintenance of the Company's quality management system. Including the preparation of and revisions of the Quality Management System Manual and Quality Assurance Manual and associated quality procedures. Responsibility for the assignment, selection, indoctrination and training of personnel performing quality related functions. Assuring that the policies of the Manuals are strictly adhered to for all products manufactured and supplied by TMS-CAC. The identification and correction of conditions adverse to quality. Control of procurement documents, including the auditing of suppliers for material and services. Participating or acting as Lead Auditor in Internal and External audits. Participating in Continual Improvement to increase productivity, improve quality processes and reduce scrap. Attending Production and Pre-Manufacturing Meetings as required. Reviewing and approving Supplier procedures and documentation. Manage and coordinate all quality assurance activities with the Quality Control Supervisor, Quality, NDE Level III Manager, MT Doc. Lead, and Quality System Supervisor. Manage customer complaints, conduct root cause analysis, and address quality issues to maintain customer satisfaction. Interfacing with customers, other internal departments, and organizations outside of TMS-CAC. Performing other duties as assigned. Qualifications Must be a U.S. Citizen. Assets: ASME Section III knowledge or experience. Familiarity with quality standards such as ISO 9001, NQA-1, 10CFR50 App. B, etc. ASQC Certified. NDE knowledge. Knowledge of metallic ASTM/ASME Specifications. Knowledge of mechanical test methods of metals. Computer skills: Working knowledge of Microsoft Suite. Language: English (Spanish an asset) Able to read and interpret documents, instructions and procedures. Able to write routine reports and correspondence. Able to speak effectively before groups of customers and employees of TMS-CAC. Skillset: control plan management; process monitoring and improvement; lean manufacturing (process mapping, standard work definition, etc.); root cause analysis and formal corrective action; knowledgeable of ISO 9001 quality systems Other valuable skills: Failure Modes and Effects Analysis; design of experiments; internal auditing; calibration management; job shop manufacturing experience; up-front specification review and contract review; familiarity with inspection methods (traditional dimensional or CMM systems, NDT: penetrant, magnetic particle, or ultrasonic) Education and/or Experience Master's Degree in Science or Engineering or Bachelor's Degree in Science or Engineering with 10 years related experience. 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. While performing the duties of this job, the employee is regularly required to use hands and fingers to handle or feel and talk or hear. The employee is frequently required to sit. The employee is occasionally required to walk; reach with hands and arms and stoop, kneel, crouch, or crawl. The employee is occasionally required to lift up to 25 pounds. The vision requirements include close vision, distance vision, peripheral vision, depth perception 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. The noise level in the work environment can vary. Trident Maritime Systems is an EEO/AA employer that offers a comprehensive compensation package and opportunities for growth. As a government contractor, we adhere to regulations including the need for U.S. citizenship for certain positions. Offers of employment are contingent on and not considered finalized until the required background check and drug test has been performed and the results received and have been accessed. About Trident Maritime Systems - Custom Alloy Division Trident Maritime Systems is a global leader in providing innovative solutions for maritime and defense industries. Our Custom Alloy division in High Bridge, NJ, specializes in manufacturing high-quality seamless and welded pipe and tube solutions, as well as custom fabrications for critical applications. We serve government and commercial clients. For government, we work on military and defense contracts requiring precision and reliability. For commercial clients, we provide custom-engineered solutions across various industries. This dual focus allows us to take on diverse, high-pressure projects. Unlike mass production facilities, we create large, custom fittings tailored to specific needs. Our plant features large machines for heavy-duty work in a traditional manufacturing environment. It can be hot, cold, or dirty, but we prioritize safety and provide tools and training to ensure success. Trident Maritime Systems offers a comprehensive benefit package which includes: Cigna medical, dental; VSP vision. Flexible Spending Account & Health Savings Account (with company contributions) 401K - 3% match Paid Time Off 10 Paid Holidays Safety shoe reimbursement, $200 per year Prescription safety glasses program Voluntary Supplemental Insurance Company Paid Life Insurance Voluntary Life Insurance Paid training and development opportunities Employee referral program

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.

Key Responsibilities: * Confirm that all manufactured items are in conformance with all customer specifications. * Work together with manufacturing, engineering, and shipping departments to maximize throughput and effectiveness. * Maintain all logs and reporting supporting the ISO9001 QMS. * Deal with customers as required to resolve issues as they arise. * Prioritize work as it arrives at Inspection and assign necessary resources to complete inspection. * Deal with vendors as required to resolve issues. * Handle all paperwork promptly (RMAs, FAIRs, Corrective Actions, SCARs, etc.) Must be strong to expert at the following: * using all common measuring devices, calipers, micrometers, gages, CMM * using all common business software, Outlook, Excel, Word This is a key position at this company. This is a full time, permanent, day shift position in a growing company. This position reports directly to the President. Benefits. Vacation. 401k with match. Compucraft Fabricators Inc. Montgomeryville PA 18936.

Full-time Description The Quality Assurance Manager (QA) will be responsible for both leadership and hands on activities involving quality assurance, establishing, and validating specifications, customer complaint resolution and compliance with ISO9001 standards. As a leader in the organization, the QA Manager will be instrumental in the updates and implementation of policies and procedures to ensure that quality and regulatory standards are met. The successful candidate will plan, coordinate, and direct quality management system to comply with the ISO9001 standards. The successful candidate must have experience in managing an ISO certified quality system and has led successful recertification audits. The candidate will be the primary contact for customers on issues regarding new product inquiries and specifications, process parameters, test methods and compliance. Successful use of a structure root cause problem solving methodology is required and will be validated during the interview process. This is more than an administrative role; this is a leader who must have solid knowledge of plastic extrusion processing/compounding and product testing. A knowledge of other plastic processing such as injection molding and compression molding a plus. The QA Manager will report to the Director of Operations and will have accountability for the plant testing lab. A candidate who has experience in EH&S Management will receive additional consideration. Requirements Position Description: · Managing, auditing, and maintaining all aspects of ISO 9001; QMS program and implementation · Maintain appropriate ISO certification requirements and coordinate registration activities as management representative · Developing and maintaining the root cause and countermeasure process · Creating quality documentation, quality assurance reports and processes · Set standards for good relations and communications with customers and regulatory agencies · Reviewing products, processes, and systems on an ongoing basis to determine potential improvements to the QMS Required Skills & Competencies: · ISO Standards · Quality procedures and practices · Proficient in technical writing · Ability to communicate with customers · Leadership skills · Manufacturing processes and quality controls · Industries: Compounding, Injection Molding · Bachelor's degree Mechanical Engineering, Industrial Engineering

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

Pratt Specialty is seeking a talented, energetic, quality professional to improve, promote, and sustain the Quality Management System at Pratt Specialty for a Regional Quality Manager position. The selected individual will be hardworking with solid quality skills and a strong knowledge of the flexible films, (caste and/or blown stretch and bubble film and paper packaging as another advantage). ISO 9001 and FSSC 22000 (Food Safety) standards experience will be another critical area of expertise desired. This individual will work cross-functionally to drive strategic quality initiatives throughout the organization. Individual acts as leader and driver of all quality initiatives for plant locations; interacts and partners with manufacturing, sales and design teams, vendors and customers in meeting internal and external customer quality. The position will be home-based in Pennsylvania and will travel to facilities in the Northeast and Ohio Valley region, but also may be required to travel to facilities across the country to support the division. 60% Travel will be required. What You Will Do In Your Role: Supports safety as a top priority in training, job design and regulatory compliance. Lead the quality effort to a regional set of sites. Be capable of adding value and expertise in the flexible film and paper packaging converting areas in applicable locations. Drive the company's compliance with the ISO 90001 & FSSC 22000 (Food Safety). Quality effort includes (but is not limited to) the following: Flexible films manufacturing and paper packaging converting operations ISO 9001 certification FSSC 22000 (Food Safety) Internal audits Corrective actions Driving Fab card utilization Document Change System Measuring and test system calibration Non-Conforming material system Drive results of quality Manufacturing. Critically assess these systems and lead the organization to meaningful improvements. Create documentation where applicable to ensure ISO/BRC and other Regulatory requirements. Review product testing data, plant scrap data and customer complaints to determine areas that require improvement. In some cases, you will drive that improvement. Lead and participate in cross-functional efforts related to product quality, corrective actions and other teams related to the quality scope. This person must develop a well-rounded understanding of how our products are made; how they are used; and the implications of various product test results. Work closely with Design, Operations, Product management, Sales, and Supply Chain to drive quality results. Leads quality staff on performance of Quality metrics of shrink and waste & developing key manufacturing metrics. Expert in root cause analysis methods, statistical process control Drives plant accountabilities in the areas of: tracking vendor performance, resolution and disposition of customer complaints, investigating critical quality defects on in-process and finished products, generation and analysis of quality data and reports Supports HR with Quality employee's performance issues Focuses on plant wide issues and inter-plant initiatives including developing synergies and business opportunities to optimize other manufacturing plants Ensures product quality. Establishes and manages systems for “right first time” performance and incorporates this philosophy in the continuous improvement teams. Can create a culture where quality is fun and part of the process not overhead. Requirements Quality Management experience in flexible films manufacturing and converting, (i.e. stretch and bubble films) including product knowledge, manufacturing operations and ability to monitor and improve correct film making processes. Flexible films experience, (i.e. stretch film and bubble film). Converted paper packaging (paper bags, flooring products and sheeted paper). Knowledge of ISO 9001 standards and FSSC 22000 (Food Safety) Strong communication and interpersonal skills Desire to drive improvements (project management / leadership experience) Results oriented with the capability of balancing multiple tasks and priorities MATHEMATICAL SKILLS Able to read a tape measure with speed and accuracy. Able to calculate figures and amounts such as percentages, measurement, volume and rate. Able to apply concepts of high school math. REASONING ABILITY Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. PHYSICAL DEMANDS Employee is regularly required to walk and talk and hear. The employee is frequently required to stand; use hands to finger, handle, or feel; and reach with hands and arms. The employee is occasionally required to sit. The employee must regularly lift and/or move up to 50 pounds. Vision requirements include: close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. WORK ENVIRONMENT While performing the duties of this job, the employee is frequently exposed to wet and/or humid conditions, moving mechanical parts, and fumes or airborne particles. The noise level in the work environment is usually loud.

Job Description Pratt Specialty is seeking a talented, energetic, quality professional to improve, promote, and sustain the Quality Management System at Pratt Specialty for a Regional Quality Manager position. The selected individual will be hardworking with solid quality skills and a strong knowledge of the flexible films, (caste and/or blown stretch and bubble film and paper packaging as another advantage). ISO 9001 and FSSC 22000 (Food Safety) standards experience will be another critical area of expertise desired. This individual will work cross-functionally to drive strategic quality initiatives throughout the organization. Individual acts as leader and driver of all quality initiatives for plant locations; interacts and partners with manufacturing, sales and design teams, vendors and customers in meeting internal and external customer quality. The position will be home-based in Pennsylvania and will travel to facilities in the Northeast and Ohio Valley region, but also may be required to travel to facilities across the country to support the division. 60% Travel will be required. What You Will Do In Your Role: Supports safety as a top priority in training, job design and regulatory compliance. Lead the quality effort to a regional set of sites. Be capable of adding value and expertise in the flexible film and paper packaging converting areas in applicable locations. Drive the company's compliance with the ISO 90001 & FSSC 22000 (Food Safety). Quality effort includes (but is not limited to) the following: Flexible films manufacturing and paper packaging converting operations ISO 9001 certification FSSC 22000 (Food Safety) Internal audits Corrective actions Driving Fab card utilization Document Change System Measuring and test system calibration Non-Conforming material system Drive results of quality Manufacturing. Critically assess these systems and lead the organization to meaningful improvements. Create documentation where applicable to ensure ISO/BRC and other Regulatory requirements. Review product testing data, plant scrap data and customer complaints to determine areas that require improvement. In some cases, you will drive that improvement. Lead and participate in cross-functional efforts related to product quality, corrective actions and other teams related to the quality scope. This person must develop a well-rounded understanding of how our products are made; how they are used; and the implications of various product test results. Work closely with Design, Operations, Product management, Sales, and Supply Chain to drive quality results. Leads quality staff on performance of Quality metrics of shrink and waste & developing key manufacturing metrics. Expert in root cause analysis methods, statistical process control Drives plant accountabilities in the areas of: tracking vendor performance, resolution and disposition of customer complaints, investigating critical quality defects on in-process and finished products, generation and analysis of quality data and reports Supports HR with Quality employee's performance issues Focuses on plant wide issues and inter-plant initiatives including developing synergies and business opportunities to optimize other manufacturing plants Ensures product quality. Establishes and manages systems for “right first time” performance and incorporates this philosophy in the continuous improvement teams. Can create a culture where quality is fun and part of the process not overhead. Requirements Quality Management experience in flexible films manufacturing and converting, (i.e. stretch and bubble films) including product knowledge, manufacturing operations and ability to monitor and improve correct film making processes. Flexible films experience, (i.e. stretch film and bubble film). Converted paper packaging (paper bags, flooring products and sheeted paper). Knowledge of ISO 9001 standards and FSSC 22000 (Food Safety) Strong communication and interpersonal skills Desire to drive improvements (project management / leadership experience) Results oriented with the capability of balancing multiple tasks and priorities MATHEMATICAL SKILLS Able to read a tape measure with speed and accuracy. Able to calculate figures and amounts such as percentages, measurement, volume and rate. Able to apply concepts of high school math. REASONING ABILITY Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. PHYSICAL DEMANDS Employee is regularly required to walk and talk and hear. The employee is frequently required to stand; use hands to finger, handle, or feel; and reach with hands and arms. The employee is occasionally required to sit. The employee must regularly lift and/or move up to 50 pounds. Vision requirements include: close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. WORK ENVIRONMENT While performing the duties of this job, the employee is frequently exposed to wet and/or humid conditions, moving mechanical parts, and fumes or airborne particles. The noise level in the work environment is usually loud.

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

Quality Manager - Reading, PA Hours are 8:00am - 5:00pm Monday through Friday Supervises and coordinates activities of workers engaged in inspecting production work to ensure that product quality meets customers' expectations. Assists the Director of Engineering and Quality in planning, coordinating and directing quality control programs. Employee may perform other related duties as required to meet the ongoing needs of the organization. Essential Responsibilities: To perform this job successfully, an individual must be able to satisfactorily perform each essential duty. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Ensures the capability of the Quality Assurance Department to meet inspection requirements. This responsibility includes specifying and requisitioning inspection tools, fixtures, and other equipment. Dispositions nonconforming items and material by conferring with Sales, Materials, Production, Quality Manager and/or General Management. Determines sampling plans where no customer specified requirements exist. Maintains engineering documentation files for use by manufacturing. Obtains clarification from Sales/Engineering where critical information in ambiguous or missing. Review new item documentation and determine inspection criteria. Requisitions supplies and other consumables. Ensures that the department complies with Company policies and procedures, including employee safety. Directs set-ups for product inspection. Recommends measures to improve inspection methods and productivity. Maintains quality records per customer and internal requirements Confers with other Supervisors to coordinate activities. Contributes to the positive environment of the manufacturing team. Ensure that all work procedures within the department are performed in accordance to the established Quality and Environmental Management Systems Essential Skills: One year certificate from college or technical school; 3-5 years of related experience and/or training; or equivalent combination of education and experience. Experience in a leadership role. Ability to lead, coach and develop. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondences. Ability to speak effectively before groups of customers or employees of the organization. Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plan and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, rations, and proportions to practical situations. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exits. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Brentwood offers professional growth potential, pleasant work environment, and an excellent wage and benefits package including 401K w/employer match. Brentwood Industries, Inc., provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. At Brentwood, we have a passion for both our products and our people. Our goal as an employer is to help you excel as an individual and as part of a team by providing you with a satisfying, motivating and stimulating work experience. The varied nature of the environment at Brentwood allows you to work alongside industry professionals on a wide range of projects, contributing your knowledge and strengths to develop innovative, market-driven solutions. To begin the application process, please complete all required fields below and click “Apply” to continue. Please note: We are not working with external recruiters at this time and are not accepting unsolicited resumes.

Oversees and manages the Quality Management System and Quality Program to ensure consistent production of products that meet established quality standards. Plans, coordinates, and directs quality initiatives, working both independently and through subordinates to maintain and improve product quality. Responsibilities * Overall responsibility for the implementation, training and maintenance of the Company's quality management system. Including the preparation of and revisions of the Quality Management System Manual and Quality Assurance Manual and associated quality procedures. * Responsibility for the assignment, selection, indoctrination and training of personnel performing quality related functions. * Assuring that the policies of the Manuals are strictly adhered to for all products manufactured and supplied by TMS-CAC. * The identification and correction of conditions adverse to quality. * Control of procurement documents, including the auditing of suppliers for material and services. * Participating or acting as Lead Auditor in Internal and External audits. * Participating in Continual Improvement to increase productivity, improve quality processes and reduce scrap. * Attending Production and Pre-Manufacturing Meetings as required. * Reviewing and approving Supplier procedures and documentation. * Manage and coordinate all quality assurance activities with the Quality Control Supervisor, Quality, NDE Level III Manager, MT Doc. Lead, and Quality System Supervisor. * Manage customer complaints, conduct root cause analysis, and address quality issues to maintain customer satisfaction. * Interfacing with customers, other internal departments, and organizations outside of TMS-CAC. * Performing other duties as assigned. Qualifications * Must be a U.S. Citizen. * Assets: ASME Section III knowledge or experience. * Familiarity with quality standards such as ISO 9001, NQA-1, 10CFR50 App. B, etc. * ASQC Certified. * NDE knowledge. * Knowledge of metallic ASTM/ASME Specifications. * Knowledge of mechanical test methods of metals. * Computer skills: Working knowledge of Microsoft Suite. * Language: English (Spanish an asset) * Able to read and interpret documents, instructions and procedures. * Able to write routine reports and correspondence. * Able to speak effectively before groups of customers and employees of TMS-CAC. * Skillset: control plan management; process monitoring and improvement; lean manufacturing (process mapping, standard work definition, etc.); root cause analysis and formal corrective action; knowledgeable of ISO 9001 quality systems * Other valuable skills: Failure Modes and Effects Analysis; design of experiments; internal auditing; calibration management; job shop manufacturing experience; up-front specification review and contract review; familiarity with inspection methods (traditional dimensional or CMM systems, NDT: penetrant, magnetic particle, or ultrasonic) Education and/or Experience * Master's Degree in Science or Engineering or Bachelor's Degree in Science or Engineering with 10 years related experience. 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. While performing the duties of this job, the employee is regularly required to use hands and fingers to handle or feel and talk or hear. The employee is frequently required to sit. The employee is occasionally required to walk; reach with hands and arms and stoop, kneel, crouch, or crawl. The employee is occasionally required to lift up to 25 pounds. The vision requirements include close vision, distance vision, peripheral vision, depth perception 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. The noise level in the work environment can vary. Trident Maritime Systems is an EEO/AA employer that offers a comprehensive compensation package and opportunities for growth. As a government contractor, we adhere to regulations including the need for U.S. citizenship for certain positions. Offers of employment are contingent on and not considered finalized until the required background check and drug test has been performed and the results received and have been accessed. About Trident Maritime Systems - Custom Alloy Division Trident Maritime Systems is a global leader in providing innovative solutions for maritime and defense industries. Our Custom Alloy division in High Bridge, NJ, specializes in manufacturing high-quality seamless and welded pipe and tube solutions, as well as custom fabrications for critical applications. We serve government and commercial clients. For government, we work on military and defense contracts requiring precision and reliability. For commercial clients, we provide custom-engineered solutions across various industries. This dual focus allows us to take on diverse, high-pressure projects. Unlike mass production facilities, we create large, custom fittings tailored to specific needs. Our plant features large machines for heavy-duty work in a traditional manufacturing environment. It can be hot, cold, or dirty, but we prioritize safety and provide tools and training to ensure success. Trident Maritime Systems offers a comprehensive benefit package which includes: * Cigna medical, dental; VSP vision. * Flexible Spending Account & Health Savings Account (with company contributions) * 401K - 3% match * Paid Time Off * 10 Paid Holidays * Safety shoe reimbursement, $200 per year * Prescription safety glasses program * Voluntary Supplemental Insurance * Company Paid Life Insurance * Voluntary Life Insurance * Paid training and development opportunities * Employee referral program Onsite M - F 8 am - 5 pm

Keep our communities fed. Our focus is simple but meaningful, from our distribution centers to our offices - every employee of C&S and their family of companies works to help feed local families, neighbors and communities. In this role, you will perform the duties of counting and verifying product in the warehouse using handheld devices or forms as well as handling obsolete inventory and validating processes are in place per SOPs under the direction of the team supervisor.The Inventory Control and Quality Assurance (ICQA) Auditor will validate product to be delivered to customers as part of process to measure outbound selection accuracy. Responsibilities include assisting with research and resolution of errors. Text "CS" to 32543 to learn more about how you can become a part of our legacy. Job Description + Earn $19 per hour + Weekly Pay + Fulltime - 2ND Shift - 7 PM to 5 AM, Monday through Thursday. + Location - BETHLEHEM, PA You will contribute by: + Conducting accurate cycle count of inventory in the warehouse and make system updates as required + Researching and resolving inventory variances + Validating dating of product in the warehouse and update as required + Responding to requests for item checks in the warehouse + Coordinate the handling of obsolete and at risk inventory (vendor returns, donations, recalls) to include: identifying, communicating, adjusting and validating product + Deputize for ICQA lead as necessary for the following areas: Allocation of work between IC reps and specialists + Monitoring activity to ensure work carried out effectively, resolve issues as necessary + Using a strong knowledge of Microsoft Excel and email to communicate effectively What's a great way to stay in shape? + Continually sitting up to 90% of shift + Seldom lifting of product weighing between 1 - 60 lbs. or more + Seldom lifting of product ranging from floor to overhead + Occasionally of working on multiple levels of varying height + Occasionally climbing ladders to different levels of height + Safe handling of sharp objects including box cutting tools We offer: + Paid training provided + Weekly Pay + Benefits available from day 1 (medical, dental, vision, company matched 401k) + PTO and Holiday Pay offered + In certain locations C&S offers $100 towards the purchase of safety shoes + Career Progression Opportunities + Tuition Reimbursement + Employee Health & Wellness program + Employee Discounts / Purchasing programs + Employee Assistance Program Your work environment may include: + Grocery (Dry Goods) - about 50°- 90° The Fine Print This Job advertisement does not constitute a promise or guarantee of employment. This job advertisement describes the general nature and level of this position only. Essential functions and responsibilities may change as business needs require. This position may be with any affiliate of C&S Wholesale Grocers. Hiring immediately, to apply text "CS" to 32543 OR visit careers.cswg.com Qualifications General Equivalency Diploma - General Studies, High School Diploma - General Studies Qualifications General Equivalency Diploma - General Studies, High School Diploma - General Studies Shift 3rd Shift (United States of America) Company C&S Wholesale Grocers, LLC About Our Company C&S Wholesale Grocers, LLC is an industry leader in supply chain solutions and wholesale grocery supply in the United States. Founded in 1918 as a supplier to independent grocery stores, C&S now services customers of all sizes, supplying more than 7,500 independent supermarkets, chain stores, military bases and institutions with over 100,000 different products. C&S also proudly operates and supports corporate grocery stores and services independent franchisees under a chain-style model throughout the Midwest, South and Northeast. We are an engaged corporate citizen, supporting causes that positively impact our communities. Working Safely is a Condition of Employment at C&S Wholesale Grocers, LLC. C&S Wholesale Grocers is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. The Company provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans' Readjustment Assistance Act. Company: C&S Wholesale Grocers, LLC Job Area: Inventory Control Job Family: Finance Job Type: Regular Job Code: JC2274 ReqID: R-265129

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 About the position 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

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.

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a QA Change Control Specialist II as part of the Quality team based in Raritan, NJ. Role Overview The QA Change Control Specialist II role is an exempt level position with responsibilities for providing quality oversight over the change control process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will be responsible for managing change control activities throughout the lifecycle. Key Responsibilities Support and streamline the site change control process. Participate in change control process from initiation through completion. Schedule and participate in the site change control review board meetings. Manage change control metrics reporting. Collaborate with functional departments to resolve issues. Support drafting of standard operating procedures. Support cross-functional projects with many stakeholders. Participate in the training program for new members. Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Review change controls, SOPs, and other documentation. Require minimal direction to complete tasks, knows how to get resources and information from established internal contacts; consult with supervisor for decisions outside established processes. Drive continuous improvement. Have advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge. Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Quality Control, and Operations Technical Support. Requirements A minimum of a Bachelor's Degree in Science, Information Science or equivalent technical discipline is required. Minimum of 2 years relevant work experience is required. It is preferable that the candidate has experience working in a cGMP manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. GxP Quality System knowledge, including relevant regulations and guidances (e.g. 21 CFR, ICH Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA). Operational experience with electronic quality systems. Familiarity with core Quality Management System processes. Strong written and verbal communication skills, and analytical problem solving and conflict resolution skills. IT system lifecycle knowledge including requirements gathering, change management, implementation and continuous support is a plus. Flexible, highly motivated, with strong organization skills, ability to multi task with attention to detail. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment. Effective interpersonal skills with the ability to communicate across all levels of the organization. Ability to work independently with a high degree of accountability. Proficient knowledge of Microsoft Office. Experience in quality metrics reporting, analysis and process improvement techniques is a plus. Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint). #Li-BZ1 #Li-Onsite The anticipated base pay range is$75,972-$99,713 USD Benefits We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. EEO Statement Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. Legend Biotech maintains a drug-free workplace.

Title: Quality Manager - Food Manufacturing Overview:Sterling has helped build careers for thousands for professionals like yourself. Our expert recruiters support you at every step in the process and as a Best of Staffing company, Sterling provides exciting work with exceptional employers across the U.S. Hire Type: Direct HireBenefits: Medical Dental VisionBonus/ Incentives/ Stock Options: 401k matching Pay: $100-115k Job Summary: We are seeking an experienced Quality Manager to lead plant-wide food safety and quality initiatives at a high-volume food manufacturing facility. This role is responsible for guiding the Quality team, maintaining regulatory compliance, and driving continuous improvement efforts. The ideal candidate is an organized, hands-on leader who is confident in decision-making, cross-functional coordination, and fostering a strong culture of food safety on the production floor. Job Duties: Oversee daily quality and food safety operations in alignment with company standards and regulatory requirements. Maintain audit readiness and ensure compliance with USDA, FDA, FSMA, and customer expectations. Lead investigations into quality deviations; identify root causes and implement corrective and preventive actions. Manage hold and release programs, sanitation oversight, pest control, environmental monitoring, and laboratory testing activities. Review, update, and maintain Quality Management System documentation, work instructions, and SSOPs. Partner closely with Operations, Maintenance, and R&D to ensure processes, product specifications, and preventive maintenance programs support food safety and product quality. Serve as the primary contact for customer quality inquiries and complaint resolution. Track, analyze, and report quality KPIs to plant and corporate leadership. Provide training, coaching, and leadership development to plant personnel related to food safety and compliance. Contribute to capital project planning and annual budget activities. Qualifications: Bachelor's degree in Food Science, Biology, Microbiology, or related technical field (or equivalent experience). 5+ years of quality assurance experience in food, beverage, or related regulated manufacturing environment. Previous supervisory or management experience required. HACCP, SQF Practitioner, and/or PCQI certification preferred (or ability to obtain). Strong understanding of cGMPs, environmental monitoring, sanitation, and lab practices. Excellent communication, leadership, analytical, and cross-functional collaboration skills. Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.

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.