Regulatory Affairs Manager NeuroPace
Provide quality engineering support to build supplier relationships, successfully resolve supplier related issues and assure compliance with NeuroPace quality system requirements.
Lead quality system audits at existing and new suppliers to ensure compliance to regulations, as well as work with suppliers to develop corrective action plans when necessary. Follow up with suppliers on completion of corrective action plans and review responses for adequacy.
Support evaluation and selection of new suppliers
Support new product development efforts through supplier identification, evaluation and selection; creation of part specification and acceptance requirements, and resolution of purchased part/material non-conformances.
Manage supplier projects as well as working with suppliers on manufacturing or process improvements, including cost reduction activities or material or process changes. This also includes establishing appropriate risk documentation, and process validation requirements.
Report non-conformances to supplier and work with supplier to resolve issues and put corrective and preventive action in place to receive parts in specification.
Participate on change control board for supplier changes or new parts.
Perform trending of supplier performance and non-conformances and prepare data for management reviews
Minimum BS degree in Science or Engineering; mechanical, biomedical or industrial engineering degree preferred.
Minimum 3 years experience working with suppliers on quality issues; 5 years medical device experience preferred
Working knowledge of FDA Quality System Regulations, ISO 13485:2003 and MDD and AIMDD. Certified auditors are preferred (e.g. biomedical auditor, CQA, RAPS)
Frequent travel required
Audit experience required as well as demonstrated attention to detail, and excellent verbal, written, and negotiation skills
NeuroPace is an equal opportunity employer offering a competitive compensation and benefits package including medical, dental, vision, 401(k), and stock options.
||1375 Shorebird Way |
Mountain View, CA 94043