Quality Engineer

Veterans Sourcing Group, LLC; Saint Paul (MN); Vor Ort; USD 70.000 - 100.000; Vollzeit

Zusammenfassung

Veterans Sourcing Group, LLC is seeking a Quality Assurance professional to support laboratory compliance with ISO/IEC 17025, ISO 13485 and applicable regulations. The role involves coordinating audits, CAPA activities, and ensuring inspection readiness in a medical device or regulated setting.

The ideal candidate holds a chemistry or life sciences degree and has at least three years of technical experience, with strong communication skills to interact with cross-functional teams and external

Qualifikationen

• Bachelor’s degree in chemistry or related life sciences discipline.
• Strong knowledge of ISO/IEC 17025, ISO 13485 and/or 21 CFR 58.
• Strong verbal and written communication skills, both technical and conversational.
• Minimum of 3 years' experience in a technical role.

Aufgaben

• Support laboratory functions to maintain compliance with applicable regulations and standards.
• Collaborate with quality management and laboratory management on process improvement initiatives and audits.
• Plan, schedule and conduct vendor audits.
• Evaluate adequacy and compliance of systems through facility- and process-based audits.
• Assist in CAPA processes and corrective actions.
• Prepare for regulatory inspections (FDA or other) and support inspections.

Kenntnisse

Technical communication

Quality knowledge

Regulatory compliance

Documentation

Ausbildung

Bachelor’s degree in chemistry or related life sciences

Tools

None

Jobbeschreibung

Responsibilities will include:

• Support laboratory functions to maintain compliance with applicable regulations
• and standards, validated methods, and internal policies, procedures and work
• instructions, while promoting continuous inspection readiness.
• Collaborate with quality management and laboratory management on process
• improvement initiatives, quality trends and continuous improvement projects.
• Conduct internal and external quality assurance audits of systems, testing
• laboratories, procedures and controls used in testing activities under applicable
• regulations and standards.
• Plan, schedule and conduct vendor audits.
• Partner with global preclinical teams and Strategic Sourcing regarding new vendor
• requests and ongoing vendor needs.
• Evaluate the adequacy and compliance of systems, operations and practices
• through facility- and process-based audits and quality monitoring activities.
• Assess the accuracy, validity and overall quality of preclinical study data.
• Communicate final results of quality reviews and audits to management and
• technical staff.
• Write and publish audit and quality review reports, obtain appropriate approvals and
• distribute findings to responsible stakeholders.
• Oversee follow-up of corrections and corrective actions, escalated overdue items
• and support timely closure.
• Support or lead assigned quality projects and initiatives.
• Track audits and responses, support document review activities and maintain
• appropriate records.
• Contribute to the development and continuous improvement of quality procedures
• and processes.
• Assist laboratories in preparation for accrediting body, notified body, FDA or other
• regulatory inspections.
• Support the preclinical organization in meeting Boston Scientific Quality System
• requirements.
• Support the CAPA process in partnership with CAPA owners.
• Support compliance review meetings in accordance with site procedures.

Required Qualifications:

• Bachelor’s degree in chemistry or related life sciences discipline
• Strong technical and quality knowledge of ISO/IEC 17025, ISO 13485 and/or 21 CFR 58
• Strong verbal and written communication skills, both technical and conversational
• Minimum of 3 years' experience in a technical role

Preferred qualifications:

• Minimum of 2 years' experience working in a quality role
• Minimum of 4--5 years' experience working in the medical device industry or other
• similarly regulated industry, such as pharmaceuticals, biologics or preclinical environments