ISO 14971

Experience supporting CAPA activities Experience applying statistical methods and quality engineering tools Experience maintaining audit-ready quality and regulatory documentation Experience supporting regulatory reporting and agency inquiries Preferred Skills Experience with medical device complaint handling systems Experience developing post-market surveillance procedures and processes Experience with adverse event reporting Experience creating quality metrics, dashboards, and management reports Experience supporting internal and external audits Experience with global medical device regulatory requirements Experience updating risk assessments using post-market data Experience supporting product reliability and continuous improvement initiatives Job Responsibilities Monitor medical device performance, safety, and quality throughout the post-market lifecycle Lead technical investigations of customer complaints, product failures, and adverse events Work directly with customers to gather complete complaint and failure information Perform root cause analysis and failure analysis Conduct complaint and service data trend analysis Identify emerging product and quality issues Apply statistical and quality engineering methods to evaluate product performance Support adverse event evaluations and regulatory reporting activities Update risk management documentation and risk assessments based on post-market data Support CAPA investigations and implementation Develop and maintain post-market surveillance procedures Maintain detailed and audit-ready post-market surveillance records Support communications with regulatory agencies regarding post-market activities Participate in internal and external audits and inspections Develop quality metrics, dashboards, and management review reports Identify product and process improvement opportunities based on post-market findings Provide technical guidance on post-market surveillance and regulatory compliance requirements

Pay:

95k-120k/year Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria.

Disclaimer:

These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client.

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. 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