Senior Quality Systems Specialist

The Senior 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 manages document control transactions, site record retention, calibration and inspection activities. In addition, the Senior Quality Specialist will lead Customer complaint, CAPA and NCR investigations, manage site audit activities, support supplier quality and customer assessments and lead risk management activities where appropriate. This role may also track and trend quality data and support a site's Management Review process.

* Manage the document control processes for the site.
* Lead Customer complaint investigations and ensure complete complaint documentation.
* Lead CAPA and NCR investigations and ensure proper documentation.
* Manage the DHR and batch record release process.
* Manage record retention practices within the site.
* Coordinate site calibration activities and recordkeeping.
* Manage site audit activities and recordkeeping.
* Support supplier quality and Customer assessment activities.
* Track, trend and analyze Quality data.
* Support targeted Lean activities.
* Complete other duties as assigned.

Required:

* Bachelor's degree required in technical fields (i.e. Engineering, Chemistry, Biology).
* Minimum five (5) years of experience in a regulated industry (i.e. FDA/ISO 13485)
* Knowledge of standard quality analysis tools (Problem Solving/Root Cause Analysis)

Preferred:

* Certification: ASQ, QSR, or AAMI certification preferred.

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
* 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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