Piramal Pharma Solutions is seeking an experienced Manager, Quality Systems & Compliance to lead and maintain robust quality systems and ensure compliance with global regulatory requirements at our Sellersville site. This role is critical in supporting cGMP and regulatory compliance across manufacturing, testing, warehousing, and distribution operations for pharmaceutical drug products.
The successful candidate will ensure quality systems are effectively implemented, aligned with company quality policies, and continuously improved to meet evolving regulatory and business needs.
Key Responsibilities
Quality Systems Leadership
Serve as system administrator for electronic Quality Management Systems (eQMS), including ComplianceWire, TrackWise, Ensur, eBMR, and eForms.
Ensure effective use of quality systems to support site compliance and continuous improvement initiatives.
Review and approve quality system records, including deviations, CAPAs, change controls, and training records.
Training Program Management
Oversee all site training activities and ensure compliance with regulatory and internal requirements.
Partner with department heads and SMEs to develop, implement, and maintain training curricula.
Provide guidance and training to end users on quality systems and processes.
Document Control
Manage the site SOP program and overall document control lifecycle.
Oversee document management activities, including Master Batch Records and protocols.
Compliance & Governance
Lead Quality System Committees (QSCs) and review boards, including Deviation, CAPA, and Change Control Review Boards.
Provide quality system metrics on a weekly, monthly, and quarterly basis.
Manage Annual Product Reviews (APRs).
Oversee complaint, FAR, and recall management processes.
Manage Quality Technical Agreements (QTAs).
Audit & Supplier Management
Lead the Supplier Management Program.
Manage internal, external, client, and regulatory audits.
Actively support regulatory inspections and client audits.
Data Integrity & Computer Systems
Serve as Site Data Integrity Compliance Officer (DICO).
Manage the site Data Integrity Program.
Oversee the Computer System Validation (CSV) program.
Support implementation and upgrades of electronic systems.
Continuous Improvement
Collaborate with the corporate quality team to implement global policies and procedures.
Support site quality improvement initiatives and special projects.
Ensure adherence to site safety standards.
Perform additional Quality Systems & Compliance activities as assigned.
Required Qualifications
Education
Bachelor's degree or higher in a scientific, quality assurance, or technical discipline.
Experience
Minimum of 10+ years in a manufacturing environment with QA, Quality Systems, and/or Compliance experience in a cGMP/FDA-regulated industry.
At least 5 years in a supervisory or managerial role.
Technical & Functional Skills
In-depth knowledge of global pharmaceutical regulations (FDA, EMA, PDMA, ANVISA, TGA, DEA).
Strong understanding of Quality Management Systems for non-sterile pharmaceutical manufacturing.
Hands-on experience with eQMS platforms (DMS, LMS, eBMR).
Proven experience in audits, supplier management, and data integrity.
Excellent organizational, communication, and cross-functional collaboration skills.
Proficient in Microsoft Office and standard business systems.
Ability to manage multiple projects and priorities simultaneously.
$88k-132k yearly est. 5d ago
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Inventory Quality Specialist
Midea America
Quality engineer job in Bath, PA
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
$58k-90k yearly est. 4d ago
Advanced Workflow Engine (AWE)--EFT
Tekgence Inc.
Quality engineer job in Allentown, PA
1.Workflow Design Development (AWE)
o Build advanced, modular EFT workflows conditional logic, parallel processing, retries backoff, idempotency, SLA timers, and robust notifications (email).
o Implement processes that wait for multiple input files, fan out to multiple vendors, and produce a single consolidated acknowledgment signal file.
o Handle validations, transformations (PGP encrypt decrypt, compress uncompress), and archiving.
2.Platform Configuration Administration
o Configure Sites, Users Groups, permissions, virtual folders, connection profiles (SFTPHTTPS Workspaces).
o Manage DMZ Gateway, high availability clustering, and redundancy across SDC and BOC (or equivalent data centers).
o Administer certificate skeys (TLSPKI, SSH keys, PGP), cipher policies, mTLS, IP restrictions, and audit logging.
3.Networking Load Balancing
o Collaborate with teams on SSL pass through offload, persistence, and health monitors.
o Troubleshoot intermittent connectivity across firewalls, Zscaler proxies, NAT, routing, and DNS, driving root cause and permanent fixes.
4.Integration Automation
o Integrate EFT with external systems via RESTSOAP APIs, databases (SQL Server), and ticketing (ServiceNow).
o Script tooling (PowerShell) for automation, test harnesses, and repeatable deployments.
$71k-88k yearly est. 2d ago
Food Safety Quality Assurance Manager Protein (2nd Shift)
The Clemens Food Group 4.5
Quality engineer job in Hatfield, PA
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
$69k-100k yearly est. 60d+ ago
Clinical Quality Manager
Artech Information System 4.8
Quality engineer job in Collegeville, PA
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
$78k-108k yearly est. 60d+ ago
Supplier Quality Manager
Lancesoft 4.5
Quality engineer job in Raritan, NJ
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.
$88k-111k yearly est. 1d ago
Quality Technician
Pennpak Solutions
Quality engineer job in Bethlehem, PA
PennPak Solutions, in Bethlehem, PA. is seeking a dynamic and self-motived Quality Technician to join our team. This individual will provide Quality oversight during production and have the ability to fill in, as needed, when manufacturing is down. The ideal candidate shall have prior experience in food manufacturing and have flexibility to accommodate the needs associated with an entrepreneurial business start-up.
Responsibilities and Expectations
Key Responsibilities:
Manage, approve, or reject all raw materials, packaging materials, labeling and finished products.
Monitor the facility, personnel, and visitors for adherence to GMPs.
Perform Pre-Operational Inspections per the stated frequencies.
Perform monitoring and verification activities related to food safety and food quality. Activities may include but are not limited to analytical product testing, packaging attribute and weight assessments, label review, food safety verification, sanitation and environmental swabbing, etc.
Ensure adherence to Food Safety and HACCP critical control points and preventive controls.
Lead and manage investigations and corrective actions as appropriate.
Review all production records for legibility, accuracy, and completeness.
Oversee document control within production/quality records to ensure the latest revision of procedures are being used at all times.
Assist with cleaning duties as assigned. The team member will be responsible for their immediate area during standard production and will be assisting with equipment and facility cleaning as needed and directed during down periods.
Engage in learning and working in other areas of production as needed.
Other duties as assigned by the QA Manager.
All other duties assigned as needed.
Qualifications:
Proficiency with data entry and basic computer skills required.
Must be able to lift at least 35lbs.
Ability to reach, pull, push, stop and bend frequently.
Ability to stand for approximately 80% of 12-hour shift.
Must be able to problem solve, show a high attention to detail and be very self-motivated.
Excellent verbal, written, and interpersonal skills.
High school diploma or equivalent GED certificate
Experience in food manufacturing facility preferred.
Experience in record keeping, data entry and stock management is a plus.
Work Environment:
This position may require working overtime or weekends to meet business needs.
This position is on the manufacturing floor almost constantly. Exposure to allergens such as milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, sesame, and soybeans is likely.
$29k-45k yearly est. 60d+ ago
Quality Technician, 7a-7p (2,3,2)
Sharp Packaging Services 3.7
Quality engineer job in Allentown, PA
Quality Technician
The role of the Quality Technician is to ensure GMP compliance throughout the execution of labeling, assembly, and packaging activities. The Quality Technician is responsible for supporting Operational activities that directly impact manufacturing. The primary activities include performing line clearance verifications, adjustment of AQL sampling quantities, completing real-time and end of batch review of documentation such as batch records and logbooks, and taking Finished Good and Special Request samples as required throughout the labeling, assembly, and packaging processes.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
The following is a list of minimum responsibilities required of the Quality Technician position. Other duties may also be assigned.
• Ensure all batch record documentation is accurate (lot numbers, expiration dates, items number and related data are consistent throughout the record; AQL Report is accurate), and complete.
• Read and understand process steps within the batch record to ensure compliance during the packaging process.
• Review batch records for any additional requests, memos, deviations, change controls, material request transfer forms, etc. and ensure appropriate actions are taken.
• Ensure room/equipment cleaning logs have been completed as applicable.
• Pull all Finished Good (Reference, Retain and Reserve) and special request samples as required in batch record and material request transfer forms
• Support operations by completing line clearance verifications after room clean activities.
• Responsible for notifying supervision if any abnormal occurrences are observed while performing job responsibilities.
QUALIFICATIONS:
To perform this job successfully, the candidate must be detailed oriented. 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.
• One (1) year of related pharmaceutical experience or training.
• General knowledge of FDA regulations related to cGMPs is required.
• General knowledge of quality control/assurance is required.
• Strong written and verbal communication skills are required.
• Strong foundation in basic mathematical skills (addition, subtraction, multiplication, and division)
• Strong problem solving and critical thinking skills.
• Strong organizational and planning skills are required.
SUPERVISORY RESPONSIBILITIES:
This position will have no supervisory responsibilities.
PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE:
An associate or bachelor's degree is preferred
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 sit, stand, walk and use hands to finger, handle, or feel. The employee is occasionally required to reach with hands and arms. The employee must occasionally lift and/or move up to 35 pounds. Specific vision abilities required by this job include close vision, and color vision.
WORK ENVIRONMENT:
The work environmental 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 exposed to moving mechanical parts. The noise level in the work environment is usually moderate.
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.
$29k-36k yearly est. Auto-Apply 22d ago
Process Engineer
Coherent Corp 4.6
Quality engineer job in Easton, PA
Primary Duties & Responsibilities Responsible for efficient operation of crystal growth processes, including source synthesis, seed preparation, bulk crystal growth, post growth treatment, and any other related processes. Creates and maintains SPC charts for critical crystal growth processes. Lead the implementation of processes and technology from the crystal growth R&D to crystal growth manufacturing. Work with the R&D team of engineers and technicians on projects and specific tasks related to the development and manufacturing of Silicon Carbide crystals. Within the framework of R&D projects and commercial manufacturing run by AMD designs, schedules and carries out crystal growth, materials processing and other experiments and analyzes their results. Maintains technical drawings of crystal growth and related equipment parts. Characterizes produced single crystals using all necessary tools and techniques, including those available at AMD, as well as from other sources inside and outside Coherent. Investigates and models experimental data to establish correlations and trends. Characterizes technological processes, establishes the process reliability and "bottlenecks". Finds innovative solutions to technical problems and optimizes crystal growth so it leads to the improved product quality, increased yields and throughput. Generates scientific and technical ideas and contributes to the Intellectual Property Portfolio of Coherent by writing IP disclosures and patents.
Education & Experience
* Bachelor's in Material Science and Engineering, Physics, Chemistry or a related area of study
* Master's or Ph.D. degree in related technical field is a strong plus.
* 3 to 7 years of relevant manufacturing experience
* Knowledge of technological processes used in the process of device manufacturing, including crystal growth and epitaxy
* Hands-on experience in materials characterization using electronic, optical and x-ray methods
* Experience in evaluation and optimization of technological processes
* Experience in writing proposals, reports and preparation of presentations in an R&D environment
* Experienced with Total Quality\Business Excellence and business process management
* General knowledge of crystal growth principles and practice.
* Hands-on experience in the operation of furnaces, power supplies, vacuum systems and infrastructure equipment.
* Knowledge and hands-on experience in maintenance of furnaces and associated laboratory instruments and facilities.
Skills
* Understanding of crystal growth principles and related physical/chemical phenomena, including thermodynamics of chemical reactions, heat and mass transfer
* Knowledge of scientific principles and practice of crystal characterization, including electrical, optical and x-ray characterization methods
* Extensive hands-on experience with statistical tools and their use for process characterization, including failure and error analysis. Knowledge of Design of Experiments (DOE).
* Knowledge of theory and practice of vacuum equipment and processes
* Familiarity with programs and software used for engineering calculations, modeling and data processing
* Ability to handle multiple priorities and work with employees and customers in a multi-cultural, global team environment
* Excellent interpersonal and communication skills
* ITAR compliance requirement: Individual must be a U.S. Citizen, Permanent Resident Alien, or Protected Individual per 8 U.S.C. 1324b(a)(3).
Working Conditions
* Normally 9-5
* May require longer working hours in order to complete mission critical tasks
Physical Requirements
* Hands-on work
* Must be able to lift 25 lb. parts
Safety Requirements
All employees are required to follow the site EHS procedures and Coherent Corp. Corporate EHS standards.
Quality and 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 Corp.:
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
ITAR/Export Compliance
This job requires that an individual come into contact with raw materials, products, equipment / machines, software or technology controlled by the Export Administration Regulations or the International Traffic in Arms Regulations. The job must be filled by a U.S. person or a person for whom a valid export control exception has been obtained, or is not required, from the U.S. Government.
Coherent Corp. is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
If you need assistance or an accommodation due to a disability, you may contact us at ******************************.
$70k-88k yearly est. 60d+ ago
Quality Technician
Wausau Equipment Company, Inc.
Quality engineer job in Shoemakersville, PA
Knowledge, Skills, & Abilities:
Strong problem-solving mindset.
Team-oriented with effective communication skills.
Committed to accuracy, consistency, and continuous improvement.
Frequent use of hands and inspection tools in a manufacturing environment.
Able to balance quality control with production demands.
$29k-44k yearly est. 23h ago
Quality Technician
Alamogroupcareercenter
Quality engineer job in Shoemakersville, PA
Knowledge, Skills, & Abilities:
Strong problem-solving mindset.
Team-oriented with effective communication skills.
Committed to accuracy, consistency, and continuous improvement.
Frequent use of hands and inspection tools in a manufacturing environment.
Able to balance quality control with production demands.
$29k-44k yearly est. 23h ago
Quality Technician
Hpfairfieldcareercenter
Quality engineer job in Shoemakersville, PA
Knowledge, Skills, & Abilities:
Strong problem-solving mindset.
Team-oriented with effective communication skills.
Committed to accuracy, consistency, and continuous improvement.
Frequent use of hands and inspection tools in a manufacturing environment.
Able to balance quality control with production demands.
$29k-44k yearly est. 23h ago
Quality Technician
Bush Hog, Inc. 4.3
Quality engineer job in Shoemakersville, PA
Knowledge, Skills, & Abilities:
Strong problem-solving mindset.
Team-oriented with effective communication skills.
Committed to accuracy, consistency, and continuous improvement.
Frequent use of hands and inspection tools in a manufacturing environment.
Able to balance quality control with production demands.
$26k-34k yearly est. 23h ago
Continuous Improvement Engineer
Double h Plastics Inc. 4.3
Quality engineer job in Warminster, PA
MAIN OBJECTIVES:
Provide support to the Continuous Improvement Engineering Manager in establishing the collection, recording, development, and optimization of KPI metrics for data delivery and analysis, targeted improvement initiatives, cross-functional training, and technical support for the creation of new and the improvement of existing processes. Assist in supporting a culture of Lean Manufacturing in the operations at all Double H facilities through research, observation of production performance, and investigation for opportunities of improvement and established standards.
Assists in collection, documentation, and creation of monthly tracking reports for plant metrics; including production levels, downtime, defect rates, cycle times, OEE, and COPQ. Will complete analysis in performance variances in the aforementioned metrics, using lean manufacturing investigative tools and prepare corrective actions with reports. Maintain and update plant metrics dashboards in Power BI or a similar platform. Assist in the composing of standard work instruction documentation for all positions and assists HR teams in developing and maintaining training matrix for new employee onboarding.
PRIMARY DUTIES AND RESPONSIBILITIES: Follow and promote the company's safety-first culture through proper execution and monitoring of safety procedures; including the use of all safety equipment, personal protective gear, and safety glasses (where applicable). Stops and reports ALL unsafe activities immediately.
Assist Continuous Improvement Manager in effective process evaluation, root cause analysis, corrective actions and failure analysis. Monitor scrap and waste levels for all lines and help drive reductions in waste to increase output and maximize uptime.
Project research and data recording, including: time-studies, work flow analysis, machine metrics, ergonomics and employee movements.
Develop automated spreadsheets, interactive user-forms, and dashboards using Power BI or similar tools.
Track metrics for line startup, changeovers, preventative maintenance, safety initiatives, and employee performance to evaluate the effectiveness of process changes.
Author and edit standard work instructions and single point lessons. Work with plant managers or teams to develop and train employees.
CRITICAL KPI'S:
C andidate will be measured on completion, quantity, and quality of assigned work.
Maintenance of on demand data and accuracy of the data presented.
Generation of cost saving and waste removal projects, production increases, scrap reduction and performance improvement of the plants.
Ability to work across all plants and managers to a satisfactory experience and performance level.
QUALIFICATIONS:
Education:
Associates or Bachelor's Degree in Engineering (Industrial, Manufacturing, Mechanical, Plastics, or Electrical)
Required knowledge:
Manufacturing process control
Lean Manufacturing or Six Sigma
Engineering principles (Math and Mechanical aptitude)
An ideal candidate will be/have:
Self-motivated - able to complete tasks with little assistance, choosing to do things the right way even when it takes longer or there is pressure to take shortcuts.
Extremely organized with high attention to details.
Strong written and oral communication skills.
Bold and take the initiative to act.
2-3 years of manufacturing experience.
Creativity when data collecting and problem solving.
Good interpersonal skills - comfortable speaking with, training, and interacting with people at all levels of the organization on a daily basis.
Inclusive of all ideas, and able to navigate multi-cultural/multi-language teams.
Skills/Abilities:
Strong MS Excel skills at the complex formula, advance charting, pivot table level. Visual Basic or other coding language a plus.
Strong skills in MS Teams, Power BI, DOMO or similar visual display software.
Knowledge of Pareto, 5-Why, 8D, Ishikawa (Fishbone) diagram, root cause analysis.
#IND1
$59k-74k yearly est. Auto-Apply 31d ago
Quality Technician
Tenco Services 3.2
Quality engineer job in Shoemakersville, PA
Knowledge, Skills, & Abilities:
Strong problem-solving mindset.
Team-oriented with effective communication skills.
Committed to accuracy, consistency, and continuous improvement.
Frequent use of hands and inspection tools in a manufacturing environment.
Able to balance quality control with production demands.
$26k-34k yearly est. 22h ago
Quality Technician
Alamo Iron Works 4.0
Quality engineer job in Shoemakersville, PA
Knowledge, Skills, & Abilities:
Strong problem-solving mindset.
Team-oriented with effective communication skills.
Committed to accuracy, consistency, and continuous improvement.
Frequent use of hands and inspection tools in a manufacturing environment.
Able to balance quality control with production demands.
$26k-32k yearly est. 23h ago
Process Engineer
Tata Consulting Services 4.3
Quality engineer job in Raritan, NJ
* Product formulation and launch experience. * Biomaterials and material development. * Knowledge of Medical devices and combination products; PMA familiarity. * Problem-solving using Analytical tools. * Knowledge of Design of Experiments (DOE). * Protocol development, reporting, and documentation.
* In-vitro/ex-vivo characterization of prototypes.
* Strong communication and collaboration across teams.
* Ability to work in ambiguous environments and deliver outcomes.
* Experience with self-directed teams and multitasking.
* Effective prioritization and decision-making.
* Travel up to 20% may be required (domestic and international)
Roles & Responsibilities
* Lead process design efforts from modeling through to pilot scale and qualification, including technical reviews.
* Collaborate with external suppliers, CDMOs and manufacturing facilities to develop processes. Drive selection of lab scale and pilot scale equipment.
* Drive process and product characterization to ensure rigorous technical understanding meets scale-up metrics and KPIs (such as scrap, cost and quality)
* Lead raw material suppliers through raw material iterations, correlating to product design window
* Drive execution of Learning Plans, seamlessly collaborating with Supply Chain
* Peer review, coach and develop earlier in career engineers with respect to Process Design
Salary Range $110,000-$125,000year
TCS Employee Benefits Summary:
Discretionary Annual Incentive.
Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
Family Support: Maternal & Parental Leaves.
Insurance Options: Auto & Home Insurance, Identity Theft Protection.
Convenience & Professional Growth: Commuter Benefits & Certification & amp; Training Reimbursement.
Time Off: Vacation, Time Off, Sick Leave & Holidays.
Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.
#LI-SP1
$110k-125k yearly 5d ago
Industrial Engineer
Trident Maritime Systems 4.0
Quality engineer job in High Bridge, NJ
The Industrial Engineer is responsible for driving continuous improvement across plant operations, with a focus on efficiency, productivity, and safety. Spending approximately 85% of their time on the floor, this role partners closely with production, maintenance, and engineering teams to streamline processes, implement best practices, and identify opportunities for equipment upgrades or modifications. The Industrial Engineer also develops and standardizes SOPs, ensuring consistency and compliance throughout the plant.
Responsibilities
Analyze and improve production processes to reduce waste, downtime, and costs while increasing efficiency and quality.
Develop, implement, and update Standard Operating Procedures (SOPs) for plant operations.
Partner with maintenance and engineering teams to recommend and support equipment upgrades, modifications, or replacements.
Conduct time studies, workflow analysis, and root cause investigations to support process improvements.
Monitor key performance metrics and provide data-driven recommendations for efficiency improvements.
Support safety initiatives through process evaluation, ergonomic studies, and risk assessments.
Provide training and guidance to production staff on improved processes and SOP adherence.
Collaborate with leadership to identify and implement lean manufacturing and continuous improvement initiatives.
Assist with capital projects by providing engineering input, ROI analysis, and implementation support.
Perform additional duties as assigned.
Qualifications
Strong knowledge of lean manufacturing principles, continuous improvement methods, and workflow analysis.
Familiar with natural gas furnaces, hydraulic systems, high voltage motors and large displacement pumps.
Proficiency in Microsoft Office and CAD software (AutoCAD or similar preferred).
Excellent communication and collaboration skills for working with cross-functional teams.
Ability to spend extended time on the plant floor observing, analyzing, and improving processes.
Knowledge of business principles, strategic planning, and resource allocation.
Familiar with quality systems such as ISO 9001.
Education and/or Experience
Bachelor's degree in Industrial Engineering, Mechanical Engineering, or other related engineering fields.
Journeyman-level experience in a manufacturing/industrial setting may be considered in lieu of a degree.
5+ years of industrial, process, or manufacturing engineering experience.
Preferred Experience in natural gas furnaces, hydraulic systems, high voltage motors and large displacement pumps.
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 100 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
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
$70k-90k yearly est. Auto-Apply 60d+ ago
Process Engineer
Blommer Chocolate Careers 4.5
Quality engineer job in East Greenville, PA
We offer HEALTH & DENTAL BENEFITS DAY 1 OF HIRE! Blommer understands that our employees are our biggest assets. With this in mind we offer a generous benefits package, tuition reimbursement, and 10 pounds of free chocolate for your birthday!
Blommer has been providing delicious, high quality chocolate and cocoa products to customers since 1939. Built as a family business, we are continuing to grow and are looking for motivated and reliable associates to help in our mission of Bringing Chocolate to Life!
Job Purpose:
The Process Engineer is responsible for improving the efficiency and assuring the reliability of all manufacturing processes through the identification of inefficiency and waste, monitoring process and equipment performance, and analyzing process metrics to a standard. The process engineer is regarded as an area expert and relied on to actively troubleshoot and implement solutions to difficult processing and equipment related failures. Implementation of deliverables may include the creation and maintenance of Block Flow Diagrams (BFD), Process Flow Diagrams (PFD), Piping and Instrumentation Diagrams (P&ID), process narratives, functional descriptions, and asset evaluations to support operations. The process engineer is expected to work effectively both individually and in teams to produce deliverables which improve OEE and reduce business risk. To mitigate business risk, the process engineer is responsible to track, identify, and improve asset health, which may require the need to rebuild, overhaul, or replace assets. This includes both R&M and Capex funded projects.
Essential Duties and Responsibilities:
Process and Equipment Expertise
Considered the subject matter expert (SME) in their assigned value stream
Regarded as an equipment expert in their assigned value stream
Manages and supports asset life cycle including new equipment planning, specification, use, maintenance, and disposal
Analyzes and tracks equipment performance against defined standards
Assists in evaluating and improving equipment reliability
Partners and collaborates with equipment OEM's
Attend external training opportunities as needed
Implement Process Improvement
Identify opportunities to effect process improvements; create teams involving all site functional areas to achieve process improvements and overall process efficiencies.
Process data, lean and other TQM methods to problem solve and identify inefficiencies within the operating processes
Evaluate data collection methodology and score to ensure proper analysis of processes
Design engineering solutions that meet all quality, safety, maintenance, financial and operator requirements.
Plan, coordinate, and execute identified solutions.
Create Standard Operating Procedures (SOP's) for process improvements.
Train and mentor affected employees in process modifications.
Create and apply ongoing metrics and data to validate process improvements are maintained and meeting expectations.
Perform Troubleshooting & Capital Projects
Investigate issues as they arise and implement necessary solutions to maintain operations within defined expectations of quality and safety.
Initiates and attends Kaizen events
Support project engineering deliverables, including the creation of scope, schedule, cost, and savings
Complete project design deliverables such as BFD, PFD, P&ID, process narratives, and equipment layouts.
Carry out process commissioning and start up deliverables.
Assist with oversight of process equipment installation.
Execute capital projects associated with equipment rebuilds, overhauls, and minor equipment replacements.
Drive company-wide best practices for capital projects, including engineering design standards, and capital project management systems.
Support the development of annual capital and R&M budgets.
Operate within the core values of respect and care for others
Note: The employer reserves the right to change or assign other duties to this position
Skills and Work Experience Requirements:
Five (5) years' experience in manufacturing environment; food industry preferred.
Experience in: Engineering design, Process engineering, Project management.
Proficient in current computer software - Microsoft Office, auto CAD, MS projects.
Read and interpret engineering and architectural plans and schematics.
Knowledge and application of lean tools, statistical tools, root cause analysis, failure mode & effect analysis.
AutoCAD and MiniTab experience preferred.
Working knowledge of financial spreadsheets and budgets.
Education:
Bachelor's degree in Chemical, Mechanical, Electrical, Industrial, or Manufacturing engineering or related field
Blommer Chocolate Company provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
$62k-75k yearly est. 11d ago
Quality Technician
Baker Manufacturing Company LLC 3.9
Quality engineer job in Bechtelsville, PA
Job Title: Quality Technician
Department: Quality Department
Job Function: Quality Control, Calibration, Auditing
FLSA Status: Salaried Non-Exempt
Reports To: Director of Quality
Schedule: 1
st
Shift
SUMMARY
The Quality Technician is responsible for driving quality system excellence and ISO 9001 compliance at the Pennsylvania facility while supporting corporate-wide quality initiatives. This role leads internal audits across all locations, manages RMA and calibration programs for the PA site, supports NSF certification processes, and performs investigations into incoming and in-process quality issues.
This position collaborates cross functionally to improve quality performance, maintain regulatory compliance, and support data-driven decision-making across production, supplier management, and customer feedback.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Serve as primary ISO 9001 internal audit lead for all facilities and supports the Director of Quality for the yearly registrar audit.
Maintain and improve QMS documentation, procedures, and records for the PA facility.
Coordinate NSF audit preparation and ongoing certification maintenance.
Support customer, regulatory, and 3rd-party audits.
XRF inspection of incoming brass to confirm lead-free.
Issue certifications to customers for country of origin, Prop 65, AIS, etc.
Lead corrective action (CAPA) activity for PA facility and support corporate CAPAs.
Oversee supplier corrective actions and validate results as necessary.
Manage and process RMA activity; coordinate disposition and root-cause actions.
Support production operations regarding any quality issues and identify potential issues for preventative actions.
Manages the calibration program for PA facility and coordinates external calibration vendors.
Support containment, root cause analysis, and verification of effectiveness for corrective actions.
Identify and drive improvements in inspection, audit, and documentation processes.
Support continuous improvement initiatives.
Assist with the maintenance of training records for the PA facility.
Manages the shelf-life program for the facility.
Process non-conformance reports.
SUPERVISORY RESPONSIBILITIES
This position has no direct reports but may direct daily activities for both support and production personnel, or for trainees under the guidance of Management.
TRAVEL
Occasional travel may be required (less than 10%) for training, supplier visits, or off-site calibration/lab support.
QUALIFICATIONS
REQUIRED
High school diploma or GED required; Associate degree in a technical discipline or formal metrology training preferred (GD&T).
3+ years manufacturing quality or QMS administrator/auditor experience.
Knowledge of ISO 9001 standards and internal auditing methodology.
Experience with nonconformance investigations and corrective actions.
Strong proficiency with MS Office and ERP-based quality workflows.
Excellent communication and documentation skills.
PREFERRED
Calibration program oversight experience.
NSF or third-party compliance experience.
Familiarity with machining environments print reading.
Root cause and problem-solving methodology training (8D, A3, PDCA, etc.).
ASQ Certification (CQE, CQT, or CQA) a plus.
PHYSICAL DEMANDS
Frequent standing, walking, and manual handling of parts and gaging equipment.
Occasional lifting of materials up to 30 pounds.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to walk. The employee is occasionally required to stand. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.
WORK ENVIRONMENT
Must adhere to safety protocols and maintain a clean, organized work area. The noise level in the work environment is usually moderate, but at times very loud.
How much does a quality engineer earn in Bethlehem, PA?
The average quality engineer in Bethlehem, PA earns between $57,000 and $97,000 annually. This compares to the national average quality engineer range of $61,000 to $103,000.
Average quality engineer salary in Bethlehem, PA
$74,000
What are the biggest employers of Quality Engineers in Bethlehem, PA?
The biggest employers of Quality Engineers in Bethlehem, PA are: