Sr Quality Systems Spec

HM's Top Needs:

1. Experience in medical device, pharmaceutical and/or a regulated environment.

2. Experience in large scale projects with interaction across numerous functions and stakeholders.

3. Experience in quality system management.

Education Required:

Years' Experience Required:

Requires a Bachelors degree and minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience.

Responsibilities:

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).

Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

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