Quality Specialist

Quick Facts

• Role: Quality Specialist
• Location: Plymouth, MN (onsite)
• Schedule: Monday through Friday, 8:00am to 5:00pm

Description

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. The role coordinates document control transactions, site record retention, calibration and inspection activities, facilitates customer complaint investigations, assists in audit coordination, supports supplier quality and customer assessments, and supports risk management activities where appropriate. The role may also track and trend quality data and support the site Management Review process.

What You Will Do As a Quality Specialist

• 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.

Requirements

• Associates degree and two years of experience in Quality in a regulated industry (i.e. FDA/ISO 13485).
• In lieu of a degree: high school diploma or GED and 6 years of experience in a regulated industry.

Preferred

• Experience working in a manufacturing environment.
• Previous Quality Specialist experience and a strong understanding of Quality Management Systems.
• Experience with document control and working with online document repositories.
• Experience working with applications such as Propel, Windchill, or SAP.
• Knowledge of MS Office Suite applications including Excel and PowerPoint.
• Previous experience with Customer support including responding to Customer complaints or requests information about product documentation.

Other

• Customer focused mindset; responds with a sense of urgency.
• Teamwork: collaborates with others and supports team actions professionally.
• Results: manages work tasks effectively, detail oriented, strives for continuous improvement, ability to analyze technical issues, ability to cope with change and shifting priorities.
• Communication: constructs clear written communication and keeps manager and co-workers informed.

Benefits

• Market competitive pay
• Extensive paid time off and added holidays
• Excellent healthcare, dental and vision benefits
• Long- and 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 continuing education programs
• Excellent opportunities for advancement in a stable long-term caree
• Pay range: $63,750.00 - $78,750.00; eligible for bonus participation