Senior Quality Engineer - production, supplier, medical device

Company: InnoTech Staffing
Location: Burlington
Posted on: February 13, 2026

Job Description:

Job Description Job Description 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. · 5 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. · 5% 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.

Keywords: InnoTech Staffing, Concord , Senior Quality Engineer - production, supplier, medical device, Engineering , Burlington, New Hampshire