Medtronic Quality Systems Manager in North Haven, Connecticut
Quality Systems Manager
North Haven, Connecticut, United States
3 days ago
Plan, direct and monitor Quality Assurance (QA) activities to ensure that components and finished products are processed in accordance with internal and external policies and procedures to produce devices that meet specifications and satisfy the customer. Work as part of the Focus Factory management team to achieve Focus Factory and company goals. Ensure that the Focus Factory operates in a state of compliance with internal policies and procedures as well as domestic and international regulations and standards (e.g. FDA, ISO, MDD).
Provide leadership and technical support for plant and company product, process, or design improvement projects. Lead and direct quality system improvement programs in the plant.
Reports to North Haven QA Director. Direct reports include Quality Principals, Quality Engineers and Quality Supervisors and Technicians.
•Act as the Focus Factory Quality Representative and conduct all Focus Factory Corrective Action Boards.
•Establish and implement a Quality System that complies with domestic and international quality system requirements and guidelines.
•Evaluate compliance of raw materials and processed product with specifications and customer requirements.
•Develop and implement a continuous improvement program for product quality.
•Review and approve process and product changes notices.
•Ability to define problems, collects data, establish facts and draw valid conclusions.
•Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
•Ability to effectively present information to large groups.
•Good communication skills (presentation, written, and oral). Proven leadership skills.
•Must be able to recognize and support plants performance and priorities.
•Advocate a team concept. Proven ability to motivate personnel in order to balance staffing strength with profitability and growth.
•High energy level, capable to handle multifaceted projects in conjunction with normal activities.
•Well-developed interpersonal skills; ability to get along with diverse personalities.
•BS/MS in Science or Engineering.
•Six Sigma Black Belt and/or Lean Manufacturing certification preferred.
YEARS OF EXPERIENCE:
•Experience: 8+ years of experience in a leadership role in QA/manufacturing environment in a medical device company or other regulated, critical end-use product industry. Mechanical assembly and chemical manufacturing processes.
•Demonstrated analytical and data based decision making skills, statistical sampling and analysis and proficiency with Minitab statistical software. CQA/CQE
•Knowledge of medical device regulations, a plus.
•Strong oral and written communication, computer (Word, Excel and Powerpoint).
•Strong organizational skills.