Manager, Quality Operations

Manager In Quality Engineering

This position works out of our Plano, TX location in the Neuromodulation Division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.

We are seeking a passionate Manager In Quality Engineering to lead and develop an engineering team responsible for operations quality, design changes, transfer projects, and post-market surveillance within assigned product areas. The manager will be responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established requirements, standards and agency regulations.

What You'll Work On:

• Provide leadership in direct support of medical device manufacturing.
• Management and development of Quality Engineers and Technicians.
• Own the activities of the Post-Production Quality Engineering team.
• Ensure successful planning, management and execution of area projects.
• Provide Quality Engineering Body Of Knowledge guidance and leadership to department and organization.
• Passionately find opportunities to assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
• Purposefully identify and lead activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.
• Define and implement Process Control & Monitoring systems for KPIV and KPOV throughout the product lines Critical Parameter Management.
• Provide influential peer leadership with international partner site to drive quality improvements.
• Approve/author experimental plans, protocols and reports, including supporting teams on appropriate statistical analysis techniques.
• Identify Quality Initiatives and lead multi-functional teams to complete them.
• Provide enthusiastic, diligent, and fact-based communication to Sr. Management team, peers and team.
• Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.
• Lead the Nonconformance and Real-time data management portions of the quality System.
• Be an effective member of the cross-departmental Functional Management Team to foster continuous quality compliance, cost, and improvements.
• Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.

Required Qualifications:

• 4-year degree; industry certification or advanced degree, electrical or mechanical engineering preferred.
• Class III or II medical device experience (catheter experience preferred).
• 5+ years in quality desired with roles of increasing responsibility, impact, and scope within a manufacturing support environment.
• Demonstrated performance and results nonconformance management and reduction, value improvement, risk reduction, and cost containment.
• Deep understanding of risk management in design, manufacturing and post-market surveillance.
• Demonstrated and impactful experience in process improvement (KPIV, KPOV, Fishbone, Is/Is Not, QFD), Six Sigma, product and process qualification and validation, Process Control & Monitoring (SPC).
• Strong project management and people leadership skills required.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback to build positive relationships and improve business results.
• Work effectively within a team in a dynamic environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multi-tasks, prioritizes and meets deadlines in timely manner.
• Strong interpersonal skills, planning, and follow-up skills and ability to hold others accountable.

Preferred Qualifications:

• 4 years Management experience.
• Lean Six Sigma Black Belt strongly preferred.
• ASQ Certified Quality Engineer strongly preferred (CQE, CRE).
• Experience working in a broader enterprise/cross division business unit model preferred
• Ability to travel approximately 5-10%, including internationally

The base pay for this position is $97,300.00 $194,700.00. In specific locations, the pay range may vary from the range posted.