Overview
Quality Systems Specialist Jobs in Lakeville, USA at 6AM City, LLC
Job Description
Job Title:
Quality Systems Specialist
Client:
Medical Device Manufacturing Company
Duration: 10 months
Location:
Brooklyn Center, MN 55430
Shift: 1st Shift – (Flex in office and home 1-2 days on site per week)
Technical Skills
Must Have:
- CAPA
- LMS
- QMS
- Training experience
Nice To Have
- QMS Simplification
HM’s Top Needs
- Experience in regulated industry (preferably medical device or pharma)
- Experience managing Quality Management System (QMS) documents and systems and Learning Management Systems (LMS)
- Ability to manage multiple projects
- Support for QMS documentation, LMS, training systems, document control, etc.
- High level of customer service and attention to detail
Education Required
- Bachelor’s Degree
Experience Required
- 3-5 years+
Responsibilities
- Oversee development and maintenance of quality programs, systems, processes, and procedures to ensure compliance with policies and standards.
- Provide expertise in interpreting policies, regulations, and guidelines for compliance.
- Work with entities to enforce requirements and meet guidelines.
- Lead audit and inspection preparation, resolve findings, and liaise with auditors and inspectors.
- Coordinate legal requests for government investigations or litigations.
- Maintain and modify quality assurance programs and policies.
- Facilitate uniform standards globally and promote best practice sharing.
Specialist Career Stream
- Individual contributor in a professional discipline or specialty.
- Manage projects from design to implementation.
- May mentor colleagues or direct lower-level professionals.
Differentiating Factors Autonomy
- Works independently with general supervision on complex projects.
Organizational Impact
- Sets objectives for own job area and contributes to project milestones.
- May involve in cross-functional assignments.
Innovation and Complexity
- Problems are generally straightforward, may require broader understanding but typically not complex.
- Recommends enhancements to systems and processes.
Communication and Influence
- Primarily communicates with internal contacts.
- Less complex external interactions.
Leadership and Talent Management
- May guide entry-level professionals or employees in support roles.
Required Knowledge and Experience
- Practical knowledge and demonstrated competence typically obtained through advanced education and experience.
- Requires a University Degree and minimum of 2 years relevant experience, or advanced degree with no experience.
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Title: Quality Systems Specialist
Company: 6AM City, LLC
Location: Lakeville, USA
Category:
