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Functional Job Family Description
The Quality Systems Manager will be responsible for developing and implementing quality improvement efforts at sites which manufacture components, assemblies, and finished medical devices. The Quality Systems Manager will ensure that quality system requirements are effectively established and maintained in accordance with ISO 13485/FDA standards and will be responsible for reporting on the performance of the quality system to management with executive responsibility for review.
KEY RESPONSIBILITIES& TASKS
Responsibility Includes the Following Tasks:
• Ensure the sites are compliant and have quality systems and processes that meet the current business needs and are prepared for the future business needs of that site. This involves the development of new capabilities and competencies.
• Understanding the business strategy, assessing, and developing the quality structure to support the strategy/business plans. Understand the skills gaps, develop plans to address those gaps, and execute those plans.
• Create long-term roadmaps and drive implementation of improvements in Operational quality performance to enhance the customer experience and to reduce the Cost of Poor Quality. Review quality processes and drive changes to improve efficiency and effectiveness.
• Lead the deployment and execution of quality objectives, targets, goals, and programs, considering the specific requirements of each site.
• Own leadership and guidance to site Quality teams on matters such as compliance, industry best practices, and the impact to the business of changes in the external regulatory environment.
• Ensure appropriate leading KPIs are in place and are reacted to in a timely manner.
• Manage personnel to develop talent and enhance engagement to improve business performance.
• Lead the development of a strong customer-focused culture throughout the site.
• Work closely with customers and foster relationships with key customers.
• Develop and effectively manage key relationships with business partners, Operations, and Commercial and Transfer leaders.
• Benchmark and network within TE and outside the company to develop new ideas, and drive these to execution.
• Identify waste in quality system processes and operations quality, and drive actions to eliminate it.
• Change agent to drive cultural change in total quality management that involves employee accountability at all levels within the plants and across functions
• Lead both internal and external audits to ensure compliance with industry, regulatory, and government standards
• Ensure any customer and/or government requirements are implemented throughout the manufacturing processes
• Supervision of Quality Managers and Senior Engineers.
• Implement and provide a transition plan for the Management Representative role, in the event of a change of position to minimize the impact on the quality system.
COMPETENCIES & SKILLS
Core Competencies:
• Technical Learning - Picks up on technical things quickly; can learn new skills and knowledge; is good at learning new industry, company, product, or technical knowledge; does well in technical courses and seminars.
• Problem Solving- Uses rigorous logic and methods to solve difficult problems with effective solutions; probes all fruitful sources for answers; can see hidden problems; is excellent at honest analysis; looks beyond the obvious and doesn't stop at the first answers.
• Ethics and Values - Adheres to an appropriate (for the setting) and effective set of core values and beliefs during both good and bad times; acts in line with those values; rewards the right values and disapproves of others; practices what he/she preaches.
• Action Oriented - Enjoys working hard; is action oriented and full of energy for the things that he/she sees as challenging; not fearful of acting with a minimum of planning; seizes more opportunities than others.
• Job Specific Knowledge, Skills and Abilities
Knowledge
• Ability to lead in a high pace environment – self-starter with a high sense of urgency.
• Excellent multi-tasking and organizational skills – ability to execute on priorities and effectively meet milestones.
• Demonstrated ability to implement proactive quality processes.
• Ability to communicate effectively throughout all levels within the organization both written and verbal.
• Ability to influence and get things done through others without direct authority.
• Strong analytical thinker with excellent problem-solving skills.
• Ability to flex work hours and willingness to travel as needed (up to 10%).
• Spanish & English (Advanced) speaking & writing.
EXPERIENCE & EDUCATIONAL REQUIREMENTS
Experience
• 7+ years of Quality leadership experience working in a manufacturing environment, ideally in a multi-national environment.
Education
• Bachelor's Degree with a scientific or engineering emphasis.
Professional Training & Certifications
• CQE/CSSBB certification desirable.
• Certified as Internal or Lead Auditor desireable
Building Effective TeamsManaging and Measuring WorkMotivating OthersValues: Integrity, Accountability, Inclusion, Innovation, TeamworkSET : Strategy, Execution, Talent (for managers)
