Job Category: Technician - Laboratory, Manufacturing, Electronics, Electrical
Job Number: 12288984
Women Back to Work (WBW) candidates will also be considered for this position.
Akraya is looking for a Supplier Quality Auditor for one of our leading clients. To be considered, please apply or call Vaibhav at 408-512-2355.
We are an award-winning staffing firm that works with many leading technology-based companies around the world. The benefits offered to our employees include Health Insurance (Medical, Dental, and Vision), Cafeteria Plan (HSA, FSA, and dependent care), 401(k) (enrollment subject to eligibility), and Sick Pay (varies based on city and state laws). If this position is not quite what you’re looking for, visit akraya.com and submit a copy of your resume. We will get to work finding you a job that is a better match at one of our many amazing clients.
Primary Skills: 21 CFR, ISO 13485, Supplier Corrective Action Requests
Duration: 12+ Months (Possible Extension)
Contract Type: W2 Only
Please apply directly with your updated resume or call Vaibhav at 408-512-2355
- BS degree in Engineering or equivalent, MS degree preferred.
- Minimum 5 years related experience in Supplier Quality Engineering or 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.
Ability to be a true team player and a partner to the cross functions teams.
- Partnership extends to Intuitive suppliers.
- Respect and consideration for client suppliers is required.
- Very high level of attention to detail both during audit conversations, and in presentation of written summaries.
- Proven and demonstrated 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.