Job Category: Technician - Laboratory, Manufacturing, Electronics, Electrical
Job Number: 12288984
Women Back to Work (WBW) candidates will also be considered for this position.
Primary Skills: 21 CFR, ISO 13485, Supplier Corrective Action Requests
Duration: 12+ Months (Possible Extension)
Contract Type: W2 Only
To follow up with any questions, please contact 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.
Akraya is an award-winning IT staffing firm and the staffing partner of choice for many leading companies across the US. We offer comprehensive benefits including 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 fit at one of our many amazing clients.
Akraya is committed to equal treatment and opportunity in all aspects of recruitment, selection, and employment without regard to gender, race, religion, national origin, ethnicity, disability, gender identity/expression, sexual orientation, veteran or military status, or any other category protected under the law. Akraya is an equal opportunity employer; committed to a community of inclusion, and an environment free from discrimination, harassment, and retaliation.