Sr Quality Engineer (PLM Implementation)

Quality Engineer responsible for medical device quality systems, change management, CAPA execution, digital quality system implementation, and validation and risk activities. Job Requirements Bachelor's degree in Engineering required 5+ years of medical device industry experience Experience with quality systems in regulated medical device environments Experience with change management processes Experience with CAPA processes Experience with PLM systems and digital quality systems implementation Experience with validation activities Experience with risk management in product or process quality environments Preferred Skills Experience supporting quality system improvements in medical device manufacturing or product development Experience implementing or maintaining digital quality platforms Experience with document control, change control, and quality records systems Experience supporting validation protocols, execution, and reporting Experience with risk assessments tied to quality and compliance requirements Job Responsibilities Support and maintain quality systems within a medical device environment Manage and support change management activities related to products, processes, and documentation Drive and support CAPA processes, including investigation, documentation, and follow-up Support implementation and maintenance of PLM and digital quality systems Execute validation activities and maintain related records and documentation Support risk management activities for products, processes, and quality system changes Ensure quality processes align with regulatory and internal compliance requirements Collaborate with cross-functional teams on quality system execution, change control, and validation efforts

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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

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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.