Senior Quality Manager Job in Minneapolis, Minnesota US
Senior Quality Manager
Description of Work:
The Senior Quality Manager - Documentation is responsible for the development, establishment and maintenance of Quality Documentation systems, programs, policies, processes, procedures and controls that ensure the performance and quality of products conform to established standards and agency regulations.
Responsibilities:
Provide overall Documentation Systems leadership for the deployment, coordination and oversight of the goals and objectives for Divisional and SJM Enterprise Documentation Systems activities to Divisional Documentation Managers and teams globally.
Provide expert level guidance and direction of the Documentation Systems Body of Knowledge
Aggressively identify opportunities to proactively assure compliance of Documentation Systems to all applicable internal, domestic and international quality regulations, to include, but not limited to:
oU.S. FDC and 21CFR11, 21CFR820
oEN ISO 13485
oCAN MDR SOR/98-282 and CAN/CSA: ISO 13485
Aggressively identify and manage Documentation Systems activities related to adding value to the organization through systems and controls improvement, risk and cost reduction, and fiscal budgetary responsibility.
Provide influential leadership with International sites to drive proactive Documentation Systems innovation and improvement.
Identify Documentation Systems Initiatives and lead cross-functional teams to complete them.
Provide diligent and fact-based communication to Executive Management team, peers, and team.
Assess resource needs to assure that the accurate level of support is provided when needed with the competencies needed.
Requirements:
Bachelor's Degree
8+ years in Documentation Control desired
5+ years leadership and management of demonstrated compliance excellence, value improvement, risk reduction, and cost management
Medical Device or other Regulated Manufacturing background
Demonstrated extensive experience with Domestic and International regulatory requirements and regulating bodies
Ability to travel internationally to support international manufacturing sites
Strong leadership skills with demonstrated ability to create momentum and deliver excellent results highly desired
Strong project management, team skills, and influential management highly desired
St. Jude Medical is an Equal Opportunity Employer
St. Jude Medical is an equal opportunity employer. We value a diverse workforce across all spectrums, including opinion and experience. We seek out creative, conscientious, confident individuals who thrive on taking initiative. In return for those qualities, we offer outstanding compensation, comprehensive benefits and opportunities for professional growth.