Associate Quality Specialist
About The Position
As an Associate Quality Specialist, you will be responsible for administering all site’s quality functions relating to customers and 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.
Requirements
- High school graduate/GED
- Two (2) years experience in a regulated industry (i.e. FDA/ISO 13485)
- PC experience and working familiarity of common desktop applications including Excel and Word.
Nice To Haves
- Customer Focused: Demonstrates a “Customer first” mindset. Responds with a sense of urgency.
- Teamwork: Collaborates with others. Works in a professional manner to support team actions.
- Results: Effectively manages work tasks. Is detail oriented and strives for continuous improvement. Ability to analyze technical issues. Ability to cope with change and shifting priorities.
- Communication: Constructs clear written communication. Keeps manager and co-workers informed.
Responsibilities
- Complete document control transactions.
- Review customer complaints and complete complaint documentation.
- Facilitate CAPA and NCR investigations and may coordinate investigation documentation.
- Review DHRs and support batch record release.
- Manage record retention practices within the site.
- Manage site calibration activities and recordkeeping.
- Support site inspection activities and recordkeeping.
- Assists in 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.
Benefits
- Market Competitive Pay
- Extensive Paid Time Off and (9) added holidays
- Long/short Term disability coverage
- 401(k) with company match
- Maternity & Paternal Leave
- Additional add-ons benefits/discounts for programs such as Pet Insurance
- Tuition Reimbursement and continues educations programs
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
