Amick Brown is seeking an experienced Supplier Quality Auditor
for our direct client.
Location: Sunnyvale, CA
Duration: 12 Months with possible extension.
Supplier Quality Auditor will organize and lead QMS evaluations of Client's suppliers using their procedures and forms. Tasks will include all preparatory work prior to the evaluation, execution of the audit, and all post-evaluation closure activities. Post-evaluation activities shall include full ownership of any SCARs that result from their executed audits. The auditor will be the primary contact with the supplier and will need to lead cross-functional meetings within the client evaluation preparation and closure.
Roles and Responsibilities:
- This position has responsibility and authority to:
- Initiate and lead Pre-Audit data gathering and cross-functional meetings.
- Coordinate with the suppliers for audit dates, participants, and pre-review documentation.
- Initiate and perform supplier evaluations as Lead Auditor.
- Resolve and archive all associated documentation and evidence associated with the evaluation.
- Initiate and lead Supplier Corrective Action Requests (SCARs) for non-conformances resulting from the evaluation. Includes all online system reporting and presentations to the SCAR Review Board.
- Track evaluation metrics and report to Supplier Quality.
- Participate in cross-functional project/process improvement meetings related to supplier evaluations or SCARs.
- BS degree in Engineering or equivalent, MS degree preferred.
- Minimum 5 years related experience in Supplier Quality Engineering or a related field as a Lead Auditor.
- Completion of a 3rd party certification for Lead Auditor is preferred (e.g., Oriel Stat-A-Matrix, BSI, ASQ, etc.).
- In-depth knowledge of medical device auditing and specifically, 21 CFR part 820 and ISO 13485.
- Full spoken and written fluency in English is required. Multi-linguistic skills preferred.
- Ability to be a true team player and a partner to the cross functions teams.
- The partnership extends to client suppliers.
- Respect and consideration for client suppliers are required.
- Very high level of attention to detail both during audit conversations and in the presentation of written summaries.
- Strong organizational, written, and verbal communication skills and the proven ability to prioritize tasks effectively in a deadline-driven environment.
- Written and verbal skills are most critical for the evaluation evidence presented.
- Proven and demonstrated the ability to evaluate complex supplier capabilities especially related to QMS and technical depth.
- Examples of technical depth include sterilization, MIM, machining and casting, plastics, electronics, and electrical systems, motors, and brakes.
- Experience with completing PPAP or PPQP processes preferred.
- Expert computer experience with Windows, MS Office, Agile, and SAP.
- Experience in a high-volume medical device company is preferred.
- Domestic and international travel will be approximately 50% per quarter.
Amick Brown is an Information Technology consulting company specializing in ERP, Data Analytics, Information Security, Application Development, Networking, and Cloud Computing. The company was founded in 2010 and is headquartered in San Ramon, California.
Regular full-time employees are eligible for the following Amick Brown provided benefits:
- 401k with company match
- Paid time off
- Sick Leave
- Short-Term Disability
- Life Insurance
- Wellness & Discount Programs