Sr Quality Systems Spec - Exempt

Job Call Details

Spotlight Call with HM: 10/30 @ 8am CST. Dial in by phone +***. Phone conference : #.

BR Max: ***/hr.

Business Round (BR) Maximum compensation: ***/hr.

HM's Top Needs:

• Experience in medical device, pharmaceutical and/or a regulated environment.
• Experience in large scale projects with interaction across numerous functions and stakeholders.
• Experience in quality system management.

Education Required: Requires a Bachelors degree with a minimum of 5 years of relevant experience, or an advanced degree with a minimum of 3 years of relevant experience.

Work Location:

MN, Brooklyn Center. Onsite requirement:
Full time.

Work with a core team responsible for integration of QMS processes across multiple locations.

Review interactions between elements of the QMS and work with key stakeholders in Development, Operations, Quality, and Supply Chain Management to ensure robust processes that ensure quality and compliance while driving business efficiency.

Working with the program manager to evaluate, plan, and execute updates to QMS procedures, quality manuals, quality plans, quality agreements, and certifications.

Evaluate and coordinate with impacted functions to determine appropriate training.

Must Have:
Minimum Experience – Requires a Bachelors degree and minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience.

Familiarity with Microsoft Office suite of applications.

Nice To Have:

• Lean / Six Sigma certification.
• Experience in project management and risk mitigation.
• Experience in acquisitions or mergers.
• Experience in medical device, pharmaceutical and/or a regulated environment.
• Understanding of FDA regulations (21 CFR 820 and Part 11) and ISO 13485.
• Strong analytical, process improvement, critical thinking, and decision‑making skills.
• Familiarity using Product Lifecycle Management (PLM) applications (Agile, Windchill).

Responsibilities may include the following and other duties may be assigned. Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines. Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance.

Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines. Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits. Coordinates legal requests in support of government investigations or litigations. Ensures the quality assurance programs and policies are maintained and modified regularly.

Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.

Specialist Career Stream:
Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

Differentiating factors:
Autonomy – Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact – May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity – Problems and issues faced are difficult, and may require understanding of…