上海招聘

职位描述：
Reponsibility:
? Support the initiation, tracking and management of document change requests to ensure requested changes meet current compliance requirements and product specifications (may include filing, auditing of change controls).
? Oversee document modifications across various types of records in the Quality System, Design Control, Device Master Records (DMRs), production, validation, and supplier files.
? Develop and implement quality related procedures
? Completes Final Product Verification / Release functions & mentors / trains less experienced associates on Final Product Verification / Release functions.
? Develop, implement and monitor quality standards for new and existing products, collaborating with R&D, Product Engineering and Operations to ensure alignment with customer expectations and manufacturing process capabilities
? Review of DHR batch records, raw data, labeling and packaging, and laboratory documentation for compliance.
? Generation of CoA and CoC documentation.
? Assist in implementing and follow-up of systematic corrective and preventive actions (CAPA) by reviewing adequacy of root cause analysis, corrections, corrective actions, preventative actions and effectiveness
? Participate in compliance (cGMP) audits, customer audits, and vendor audits; conduct internal audits of the Quality Management System.
? Assist in the vendor qualification and evaluation program; audit and collaborate with critical suppliers to development and maintain raw material specifications, material traceability and ongoing compliance standards.
? Participate in disposition of non-conforming materials.
? Develop, maintain and report internal quality metrics and trend analyses to management such as but not limited to: Deviations, CAPA, Customer Complaints, and Non-conforming Material.
? Work with cross-functional teams to assist in the development of engineering studies and validation protocols.
? Work with manufacturing personnel to ensure on-going compliance with quality system regulations.
? Work with cross-functional teams to assist in Risk Management activities and the compilation of Risk Management reports.
? Work on continuous improvement projects to identify root causes and reduce scrap.
? Develop and maintain the internal calibration program and report to management the effectiveness of the program.
? Must maintain exceedingly collaborative and effective interaction with Production and Engineering teams to proactively advance QMS as required to support world class manufacturing operations.
? Must work in partnership with Product Engineering and R&D teams to establish quality plans including the identification of measurement tools and gages and creation of operator training programs for new product introductions.
? Additional duties as assigned.

Requirements:
? Bachelor degree with at least 5 years’ experience and knowledge in the quality field for medical devices with electronics background required;
? Working knowledge & Internal Quality System Auditing experience for medical devices (ISO 13485), Certified ISO13485 Internal Auditor preferred.
? Working knowledge of risk management process (ISO 14971) and hands-on experience in risk management tools (FTA, FMEA, Risk Assessment, etc.).
? Familiar with validation and calibration requirements within the medical device manufacturing environment.
? Computer competency in Word, Excel, Power Point, Minitab, Access and databases.
? Desired CQE, CSSBB, CQA or initiative to complete certifications within two years position acceptance.
? Fluent Oral and written English.

AMETEK is a leading global manufacturer of electronic instruments and electromechanical devices with annualized sales of $4 billion. Our Corporate Growth Plan is founded on four key strategies: Operational Excellence, Strategic Acquisitions & Alliances, Global & Market Expansion, and New Products. Its objectives are double-digit annual percentage growth in earnings per share and a superior return on total capital.

AMETEK seeks talented individuals looking to develop meaningful and rewarding careers. We offer a professional environment that encourages participation and rewards creativity. We're committed to a culture that fosters diversity and recognizes the value of all colleagues.