Quality Assurance Specialist

DiaSorin•Stillwater, MN

23h•$67,500 - $82,500

About The Position

The Quality Assurance Specialist supports the administration, execution, maintenance, and continuous improvement of the Quality Management System (QMS), ensuring compliance with applicable procedures, standards, and regulatory requirements. Depending on business needs, experience, and assigned responsibilities, the role may support multiple Quality System processes and works cross-functionally to promote effective, compliant, and sustainable quality processes. The role may cover document and records management, change management, product or batch record review and release, training administration, electronic QMS administration, calibration, supplier qualification and requalification, supplier corrective actions, audits, and other QMS processes. The specialist reviews records and documentation, supports audits and inspections, contributes to investigations and improvement initiatives, and provides guidance and training on Quality System requirements. The position includes travel to supplier sites for auditing purposes, estimated at 10%.

Requirements

Bachelor's degree in engineering, life sciences, or a related field.
At least 3 years of experience in a related field or demonstrated competence within a cGMP corporate environment.
Experience using Microsoft Office, including Word, Excel, and PowerPoint.
Good communication skills.
Service-oriented mentality and strong focus on customer needs.
Strong independent and cross-disciplinary skills.
Ability to work independently with minimal supervision and as part of a team.
Ability to work in a regulated environment.
Ability to train team members on basic group procedures and tasks.
Effective process management and analytical skills.
Experience with Quality System standards and regulations such as ISO 13485, 21 CFR 820, and IVDR.
Experience with cGMP, document and change control, quality auditing, CAPA, nonconformance processes, and complaint or vigilance processes.
Problem-solving skills and ability to analyze trend data.
Initiative, sound judgment, and decision-making skills.
Computer skills and software knowledge, including proficiency in Microsoft Office applications.

Nice To Haves

Master's degree.
Familiarity with SmartSolve or other electronic QMS software.
Familiarity with SAP or other enterprise software.

Responsibilities

Support the administration, maintenance, and continuous improvement of the Quality Management System to ensure compliance with applicable procedures, standards, and regulatory requirements.
Perform assigned Quality System activities, potentially including document and records management, change management, product or batch record review and release, training administration, electronic QMS administration, calibration, supplier qualification or requalification, supplier corrective actions, audits, and other QMS processes.
Review Quality records and documentation for completeness, accuracy, compliance, and adherence to requirements; identify issues and facilitate their resolution as appropriate.
Partner with cross-functional teams to implement and maintain Quality System processes and promote consistent application of quality and compliance requirements.
Support qualification, monitoring, maintenance, and periodic review activities for assigned Quality System processes, systems, suppliers, equipment, or records.
Generate, analyze, monitor, and communicate Quality System data, metrics, and trends to evaluate QMS performance and identify improvement opportunities.
Provide guidance and training to employees on Quality System requirements, procedures, systems, and good documentation practices.
Support internal, external, corporate, customer, notified body, and regulatory audits and inspections, including preparation and follow-up.
Participate in or support investigations, nonconformances, CAPA, risk assessments, and other Quality processes requiring Quality Systems expertise.
Administer or support electronic systems used to manage Quality processes, records, training, or compliance activities.
Lead or participate in Quality System improvement initiatives, implementation activities, special projects, and cross-functional or cross-site programs.
Support other Quality System activities, including post-market, vigilance, audit, and compliance activities, according to business needs, experience, and assigned responsibilities.
Maintain applicable Quality records and ensure activities follow established data integrity and documentation requirements.
Perform other functions as required.
Travel to supplier sites for auditing purposes (10%).