Senior Quality Auditor Medical Device - Metals

Job description:

If you have an eye for detail and want to help assure quality and facility qualifying and monitoring supply chain’s via audits in the animal health, pharmaceutical and similar regulated environments space, then this is the role for you! We have upcoming projects in United States of America in 2024, 2025 and beyond!

We're looking for an auditor in the United States of America (preferably West Coast, Midwest, Southwest), Vancouver or Tijuana to perform audits within the USA It’s preferable that you be relatively close to airport that will take you to locations within local region in the USA.

We have our first 1-day on-site audit project coming up on 11 April 2024. 

We're looking for a Sr. Quality Auditor with the following knowledge and experience:

•Language: Ability to conduct audit in English, read English, and the ability to write a quality report in English. 

•Technical Qualifications:

At least five years’ experience in quality role and/or as auditor

Experience performing audits as a lead auditor

Experience as lead auditor and/or in a quality role where you have been responsible for ensuring ISO 9001:2015 and ISO 13485: 2016 compliance

Experience as lead auditor and/or in a quality role where you have been responsible for ensuring quality systems compliance

Experience as lead auditor and/or in a quality role where you have been responsible for ensuring compliance to Good Manufacturing Practices and/or ISO 9001/13485 compliance for medical device manufacturing

Experience and auditor and/or in a quality role where you have been responsible for ensuring compliance for fabricated metal production (e.g. metal production, forming, extrusion, grinding, cutting, machined metal parts, etc.).  

Preferred to have quality/auditing/consulting experience with class 1, 2, and/or 3 medical device manufacturing

The pay range for a 1-day audit is $1100 to $1400 for time spent preparing for the audit, traveling, performing the audit and writing the report. SQA will secure and coordinate audits, provide deliverables templates and guidance, and facilitate audit closure. Trave will be reimbursed separately from your audit rate or prepaid via company booking.

What you’ll do:

You will be performing quality audits and writing reports, either internally, or at suppliers to SQA’s clients. Each client has unique program needs to which you will be oriented as part of your on-boarding for each program. SQA will provide the audit tools and templates you'll need to conduct the audit effectively and seamlessly in accordance with SQA's and our client's requirements.

What to expect:

You will be part of a global quality auditing team responsible for assuring quality in the supply chains of our clients in medical devices and life sciences. Covering your local region, you will work closely with SQA’s operations center to coordinate, prepare, execute, and deliver supplier quality audits based on client audit schedules. You will work with SQA’s world-class production team to align your expert findings to the individual structure and guidelines of each client’s managed audit program.