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Quality Assurance

Description:

$16.50/hr

Monday-Friday 7:00 AM – 3:30 PM

we develop, manufacture and distribute medical devices for cardiac and vascular surgery with an emphasis on cardiopulmonary bypass, intra-operative monitoring and vascular grafting. This includes a full-line of perfusion products, endoscopic vessel harvesting products and surgical stabilization products.

Our mission is to work as a team to save one more life, today and every day. We do this by providing lifesaving technology to cardiac surgery teams around the world.

This position is responsible for inspecting, testing, and auditing of raw materials and finished product, as well as releasing finished product as applicable by site.

1. In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

2. Compile, verify, and review Device History Records to ensure accuracy and completeness per procedures. Separate into loads for release purposes.

3. Perform pre-sterile and post-sterile inspection of products according to procedure as appropriate.

4. Inspect and release raw materials, components, sub-assemblies, and finished devices according to procedure.

5. Log in non-conformances and assist in investigations as appropriate.

6. Provide inspection with assistance when needed.

7. Complete first article inspections as needed for Ann Arbor site.

8. Perform preventive maintenance as needed for Ann Arbor site.

9. Perform other duties as assigned. (rev. 5/1/12)

Qualifications

Requires a high school diploma or equivalent and a minimum of one year of quality assurance or manufacturing experience. Basic computer software skills, i.e. Microsoft Office.

Skills:

Quality assurance, Gmp, Qa, Quality control, Batch record review, Batch record, Sop, Usda, Pharmaceutical, Chemistry, Fda, Document control, Auditing, Audit, Medical device, Raw material, Regulatory

Top Skills Details:

Must have: Quality Assurance experience within inspection, documentation, and compliance

Nice to have: Metrology experience & Med Device Quality experience

Additional Skills & Qualifications:

Must have: Quality Assurance experience within inspection, documentation, and compliance

Nice to have: Metrology experience & Med Device Quality experience

Experience Level:

Intermediate Level

About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Company
Aerotek
Posted
02/22/2021
Type
Contractor
Salary Range
$24,000.00 - 41,000.00
per Year
Salary range estimated by
Location
Ann Arbor, MI, US