Quality Systems Specialist

The Quality Specialist is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. This role coordinates document control transactions, site record retention, calibration and inspection activities. In addition, the Quality Specialist will facilitate Customer complaint investigations, assist in audit coordination, support supplier quality and customer assessments and support risk management activities where appropriate. This role may also track and trend Quality data and support the site Management Review process.

This is a day shift position. Mon-Thurs = 9 hour day. Fri = remote 4 hour day.

* Complete document control transactions.
* Manage Customer complaint investigations and complete complaint documentation.
* Facilitate CAPA and NCR investigations and may coordinate investigation documentation.
* Review DHR's and support batch record release.
* Manage record retention practices within the site.
* Manage site calibration activities and recordkeeping.
* Support site inspection activities and recordkeeping.
* Coordinate internal and external audits.
* Support supplier quality and Customer assessment activities.
* Track and trend site Quality data.
* Support targeted Lean activities.
* Complete other duties as assigned.

Required:

• Associate degree
• Minimum two (2) years experience in Quality in a regulated industry (i.e. FDA/ISO 13485).

Preferred:

• Demonstrated experience with document control and reporting in a Quality Management System (QMS) and managing customer compliant process.

We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being and financial future. Here is a brief overview of what we offer:

* Market Competitive Pay
* Extensive Paid Time Off and (9) added Holidays
* Excellent Healthcare, Dental and Vision Benefits (including Commuter FSA)
* Long/Short Term Disability Coverage
* 401(k) with a company match
* Maternity and Paternity Leave
* Additional add-on benefits/discounts for programs such as Pet Insurance
* Tuition Reimbursement and continued education programs
* Excellent opportunities for advancement in a stable long-term career

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