PCG is seeking a QA Compliance Specialist to support the execution of quality and regulatory functions in the organization
Our ideal candidate:
- Ensure compliance of the AV-SH quality/business systems to applicable regulations, standards and corporate policies.
- Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
- Support external audit activities (FDA, FDB, ISO registrar audits etc.).
- Audit areas of Abbott Vascular Quality System.
- Support administration of Quality System processes (CAPAs, Internal Audits etc.).
- Generate and distribute periodic open CAPA and Internal Audit Corrective Action (IACA) reports.
- Generate compliance metrics for Management Reviews.
- Assist the organization to receive timely feedback on open corrective actions.
- Develop and conduct Quality System training Participate in cross divisional activities to integrate quality system information.
- File Quality Records (audit reports, IACAs, CAPAs etc.).
- Ensure that all responsibilities are carried out in compliance with governing regulations and standards
- Bachelor Degree in related field or equivalent experience
- 4 + years of related work experience or equivalent combination.
- Ability to deliver high quality documentation paying attention to detail
- Ability to quickly grasp complex technical concepts and make them easily understandable
- Excellent written and verbal skills
- Strong working knowledge of Microsoft Office
- Basic familiarity with the SDLC and software development
- Must be a self-starter, independent and able to produce quality work with limited direction
- Exceptional organizational skills
This is a full-time position. Candidates must be eligible to work as Full-Time W-2 employees of PCG. Sub-contracting is not available for this position.
This position includes a competitive compensation package which includes salary, hourly compensation and full benefits.
Candidates must be able to attend on-site, face-to-face interviews in Minnesota on 24 to 48 hours notice.
Project Consulting Group is Minnesota’s leading provider of management consulting services and project resources.
Since 1998, PCG has been providing Fortune 1000, Government and Mid-Market clients with our experienced, full-time Consultants that insure their top initiatives and mission critical projects are successful and delivered on-time and on-budget. Over the past 20 years, we have successfully completed over 1500+ projects across the US and around the globe.
PCG consultants are leaders who are experienced, knowledgeable, passionate about their field, and eager to deliver value to our clients. PCG’s dedicated Sales and Recruiting teams afford its consultants the benefit of consistent work on challenging projects that vary across industry, function and scale.
Choosing PCG is choosing to invest in your career. In working with PCG, you will be working with some of the leading minds in management consulting to deepen your knowledge, expand your experience, and build a rewarding career. PCG continuously works to present its consultants with exciting and challenging work opportunities. We believe in our consultants, we support them, and we are proud to share in their successes.
Role: QA Compliance Specialist
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