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Quality Systems Specialist
4 months ago
Job Title: Quality Systems Specialist (Hybrid)
Client: Medical Device Manufacturing Company
Duration: 1-year contract with possible extension
Location: Brooklyn Center, MN, 55430
Shift: 1st Shift
Job Description:
Must Have:
- CAPA
- LMS
- QMS
- Training experience
Nice to Have:
- QMS Simplification
HM's Top Needs:
- Regulated industry experience (preferably medical device or pharma)
- Experience managing Quality Management System documents and Learning Management Systems (Training)
- Ability to manage multiple projects
Education Required:
- Bachelor's degree
Years' Experience Required:
- 3-5 years+
Responsibilities:
- Oversee the development and maintenance of quality programs, systems, processes, and procedures ensuring compliance with policies and established standards.
- Provide expertise in interpreting policies, regulatory and governmental regulations, and agency guidelines to ensure compliance.
- Work with operating entities for process analyses to enforce requirements and meet guidelines.
- Lead audit and inspection preparation, resolve findings, and liaise with auditing groups and inspectors.
- Coordinate legal requests in support of government investigations or litigations.
- Maintain and modify quality assurance programs and policies regularly.
- Facilitate uniform standards worldwide and enable best practice sharing to support the company's global mission.
Specialist Career Stream:
- Individual contributor with responsibility in a professional discipline.
- Deliver/manage projects and work with stakeholders to achieve desired results.
- May mentor colleagues or direct lower-level professionals.
- Spend the majority of time overseeing projects from design to implementation.
Autonomy:
- Work independently with general supervision on larger, moderately complex projects.
Organizational Impact:
- Set objectives to meet project milestones and may be involved in cross-functional assignments.
Innovation and Complexity:
- Solve general problems and make system/process adjustments to improve job effectiveness.
Communication and Influence:
- Primarily communicate internally to share information, status, needs, and issues for decision-making support.
Leadership and Talent Management:
- May guide entry-level professionals and/or support stream employees.
Required Knowledge and Experience:
- Practical knowledge and competence typically obtained through advanced education and experience.
- University degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.