CoWorx Staffing Services is seeking a Line Quality Engineer in the Portsmouth, NH area. The Manufacturing Line Quality Engineer provides day-to-day, floor-facing quality support for production lines manufacturing combination products. This role ensures that materials, in-process activities, equipment, and finished goods meet established standards for safety, quality, and regulatory compliance. The ideal candidate is detail-oriented, proactive, and thrives in a fast-paced manufacturing environment.

Responsibilities:

• Provide on-the-floor quality engineering support to manufacturing operations.
• Perform and document line clearances for batch start, changeovers, and during production.
• Ensure labeling control requirements are met.
• Perform incoming inspection of components and materials, including visual, dimensional, and functional checks.
• Support in-process quality inspections to ensure adherence to specifications and procedures.
• Execute and document final product testing according to established methods.
• Troubleshoot and escalate quality issues identified during testing.
• Review batch records for completeness, accuracy, and compliance with GMP standards.
• Identify and address discrepancies or data integrity concerns in a timely manner.
• Initiate and support nonconformance reports and related investigations.
• Quarantine nonconforming materials as required.
• Assist with root cause analysis and CAPA activities.
• Support the calibration program and ensure timely equipment calibration.
• Perform periodic calibration of gauges, fixtures, and test equipment.
• Maintain accurate calibration documentation.
• Ensure adherence to cGMP, FDA, and ISO standards.
• Support continuous improvement initiatives to enhance product quality and efficiency.
• Assist with audits, validations, and change control activities.
• Support cross-functional quality initiatives as needed.

Desired Background/Skills:

• Bachelor’s degree in Engineering, Life Sciences, or a related field, or equivalent experience.
• Two to four years of experience in a regulated manufacturing environment, such as pharmaceutical, medical device, or combination products.
• Strong attention to detail and documentation skills.
• Ability to work effectively on the production floor.
• Foundational knowledge of quality systems, cGMP, and data integrity principles.
• Experience with combination products, device assembly, or cleanroom environments.
• Familiarity with root cause analysis tools such as 5 Whys and Fishbone diagrams.
• Knowledge of Lean manufacturing principles.
• Hands-on experience with inspection tools or test equipment.
• Familiarity with FDA regulations, including 21 CFR Parts 4, 210, 211, and 820, and/or ISO 13485 standards.

Other Information:

Manufacturing Line Quality Engineer
Location: Portsmouth, NH
Position Type: Direct Hire | Full-Time
Salary: $75,000 – $85,000
Schedule: Monday – Friday, 9:00 AM – 5:00 PM
Benefits: Comprehensive benefits package
Don’t miss out on this excellent opportunity to join a hardworking, supportive team- apply with us today to get started!
CoWorx is an equal opportunity employer dedicated to fostering a diverse and inclusive team. We believe that a varied workforce enhances our business outcomes and contributes to a brighter future for our internal teams, Field Talent, customers, and communities. We are committed to considering all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or veteran status, and we do not discriminate based on disability.
If you are a person with a disability and require assistance during the recruitment process, please reach out to us.
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Interested candidates please reference job code 245736 when responding to this ad.