Senior Quality Engineer - production, supplier, medical device

InnoTech Staffing•Burlington, MA

14d•Onsite

About The Position

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.

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.
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.

Responsibilities

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.