Quality Engineer

Mid-level quality engineering role supporting MDR remediation, process validation, risk documentation, manufacturing quality, and product change control for medical device product families. Job Requirements Bachelor's degree in Engineering, Quality Engineering, Mechanical Engineering, Biomedical Engineering, Industrial Engineering, or related field 2 to 8 years of quality engineering experience Minimum 2 years of relevant experience with a bachelor's degree, or minimum 1 year of relevant experience with an advanced degree Experience supporting, writing, and executing process validations Experience supporting, writing, and executing test method validations Experience creating and maintaining PFMEAs Experience creating and maintaining Control Plans Experience maintaining risk documentation aligned with medical device quality systems Experience performing First Article Inspections Experience with dimensional verification Experience evaluating manufacturing or packaging changes Experience working within regulated manufacturing quality systems Experience maintaining documentation and change records in Agile PLM Preferred Skills MDR remediation experience Medical device manufacturing quality experience Experience supporting product family technical files Experience with labeling, packaging, and manufacturing process compliance Experience reviewing and approving manufacturing change orders Experience performing label verification and grading activities Experience performing packaging or fit testing Experience working with manufacturing, planning, warehouse operations, and product engineering teams Experience assessing manufacturing process risks and implementing process controls Job Responsibilities Support MDR remediation activities and ongoing manufacturing quality assurance for designated product families Ensure manufacturing processes, labeling, packaging, and documentation comply with internal quality standards and regulatory requirements Conduct First Article Inspections and complete related documentation and reports Develop and maintain PFMEAs, Control Plans, and risk management documents for product families and technical files Conduct production floor observations and process tours to verify risk assessments reflect current manufacturing practices Gather input from manufacturing, quality, and product engineering teams for risk assessments and MDR updates Coordinate with product engineers on product family updates and MDR-related changes Perform packaging or fit testing, including carton dimension change evaluations Document packaging and fit testing results in formal reports Review, collaborate on, and approve manufacturing change orders Coordinate label printing and shipping activities with production line leads, supervisors, and planning Perform label verification and grading activities Generate reports for label verification, grading, testing, and inspection activities Work with warehouse personnel to obtain components required for product testing and evaluations Maintain and manage documentation and change records within

Agile PLM Pay Details:

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: The California Fair Chance Act Los Angeles City Fair Chance Ordinance Los Angeles County Fair Chance Ordinance for

Employers San Francisco Fair Chance Ordinance Massachusetts Candidates Only:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.