Senior Quality Engineer

InnoTECH Staffing is looking to hire a fulltime permanent Senior Quality Engineer – Production & Supplier Quality for an exciting and growing medical device company in Burlington, MA.

Must be a local candidate and requires onsite 5 days a week.

Must be a US Citizen or Greencard holder

Our client  is seeking a Production & Supplier Quality Engineer to support manufacturing operations and ensure that both internal assembly teams and external suppliers consistently deliver high-quality medical device components and finished products.

This role reports directly to the Director of Regulatory Affairs & Quality Assurance and plays a critical role in ensuring reliable production, strong supplier performance, and compliance with regulatory and quality system requirements.

 
Job Description:

· Oversee day-to-day quality activities within production, ensuring assemblers follow approved work instructions, inspection procedures, and quality standards.

· Support the development, implementation, and continuous improvement of incoming inspection, in-process inspection, and final release processes.

· Train assemblers and production personnel on proper assembly techniques, inspection requirements, documentation practices (DHRs, travelers), and defect recognition.

· Conduct regular floor audits to ensure adherence to production controls, cleanliness, calibration requirements, labeling accuracy, and workmanship standards.

· Lead nonconformance investigations related to internal production or supplier-provided materials; perform root cause analysis and collaborate with teams to implement effective CAPAs.

· Manage supplier qualification activities, including audits, risk assessments, monitoring of supplier performance metrics, and alignment with ISO 13485 and FDA QSR requirements.

· Work directly with suppliers to address quality issues, implement corrective actions, and maintain consistent material quality and delivery.

· Evaluate and approve supplier documentation including FAI, PPAP elements, certificates of conformance, and process change notifications.

· Support assembly fixture qualification, process validation (IQ/OQ/PQ), and development of robust production processes with Manufacturing Engineering.

· Maintain quality records, inspection results, and trending metrics; support continuous improvement initiatives aimed at reducing scrap, increasing yield, and improving production consistency.

· Provide hands-on support for testing, inspection, and measurement activities, including selection and validation of gauges, tools, and test equipment.

· Collaborate with R&D and Manufacturing to ensure smooth design transfer, proper configuration control, and production readiness for new or updated products.

 
Education / Experience Requirements:

· A bachelor's degree in a scientific or engineering discipline is required.

· years of production quality engineering, manufacturing engineering, or supplier quality experience in the medical device or similarly regulated industry.

· Strong working knowledge of FDA 21 CFR Part 820, ISO 13485, and medical device GMP requirements.

· Hands-on experience with inspection methods, metrology tools, assembly documentation, and manufacturing process controls.

· Familiarity with supplier management, auditing, and purchased component quality requirements.

· Strong communication and organizational skills, especially in a production environment.

 
Specialized Skills / Other Requirements:

· Ability to build strong working relationships with assemblers, technicians, and external suppliers.

· Strong analytical and problem-solving skills; experience with tools such as 5-Why, Fishbone, Pareto analysis, and statistical quality methods.

· Ability to read engineering drawings, tolerances, and specifications; experience walking the line in production environments.

· Capable of independently managing multiple production and supplier-related tasks with urgency and accuracy.

· Excellent technical writing and documentation discipline.

· % to 20% travel for supplier visits, audits, and inspections.

This is a full-time position with great benefits including competitive wages, medical/dental insurance, 401(k), and professional development opportunities.

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