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.