Quality Systems Specialist

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)

Must Have:

• CAPA
• LMS
• QMS
• Training experience

• QMS Simplification

• 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

• Bachelor's Degree

• 3-5 years+

• 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.

• Individual contributor in a professional discipline or specialty.
• Manage projects from design to implementation.
• May mentor colleagues or direct lower-level professionals.

• Works independently with general supervision on complex projects.

• Sets objectives for own job area and contributes to project milestones.
• May involve in cross-functional assignments.

• Problems are generally straightforward, may require broader understanding but typically not complex.
• Recommends enhancements to systems and processes.

• Primarily communicates with internal contacts.
• Less complex external interactions.

• May guide entry-level professionals or employees in support roles.

• 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.