Quality Engineer

Supports manufacturing quality and MDR compliance through process validation, risk documentation, inspection activities, packaging evaluation, and change control within a medical device environment. Job Requirements Bachelor's degree in Engineering, including Quality, Mechanical, Biomedical, Industrial, or related field

Minimum 4 years of relevant experience with a bachelor's degree, or minimum 2 years of relevant experience with an advanced degree

Experience supporting, writing, and executing process validations and test method validations

Experience creating and maintaining PFMEAs, Control Plans, and risk documentation aligned with medical device quality systems

Experience performing First Article Inspections, dimensional verification, and evaluating manufacturing or packaging changes

Experience working with manufacturing process controls, labeling, packaging, and documentation compliance

Experience reviewing and supporting manufacturing change orders

Experience maintaining documentation and change records in PLM systems such as Agile PLM

Preferred Skills Experience with MDR compliance

Experience in medical device manufacturing quality systems

Experience conducting packaging or fit testing and documenting formal results

Experience performing label verification and grading activities

Experience coordinating testing components with warehouse and production teams

Experience conducting production floor observations and process tours

Experience supporting technical files and product family updates

Job Responsibilities Conduct First Article Inspections and complete associated documentation and reports

Develop and maintain risk management documents, including PFMEAs and Control Plans, for product families and technical files

Conduct production floor observations and process tours to ensure risk assessments reflect current manufacturing practices

Collaborate with manufacturing, quality, and product engineering teams to gather input for risk assessments and MDR updates

Coordinate with product engineering teams on product family updates and MDR-related changes

Perform packaging or fit testing, including carton dimension evaluations, and document 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 teams

Perform label verification and grading activities and generate associated reports

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.