SR. QUALITY MANAGER
Location: United States - Nebraska
The Sr Quality Manager is responsible for management, direction, and coordination of all quality and regulatory compliance activities across the site in compliance with world-wire regulations, business strategies, and Customer needs. This includes providing the quality leadership encompassing Quality Systems, Quality Engineering, Microbiology, Metrology, Training and Sterilization control to ensure that the required production, quality, and regulatory standards are achieved through molding, assembly, packaging, sterilization and product release. Reports to Diabetes Care Quality Leader in NJ with dotted line reporting to the Plant Manager.
Be part of something bigger!
Our company is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
Including but not limited to:
1. Management representative of the site with regards to all Quality Systems regulation issues.
2. Manages and leads the Quality Systems and Quality Engineering teams.
3. Manages and leads the Microbiology Lab, Metrology Lab, and Sterilization control, encompassing sterile release and sterilization Validation.
4. Manages and lead the Training department and the Validation Teams for the Holdrege Plant.
5. Develops and implements strategic direction for the manufacturing plant consistent with Diabetes care and the companies quality strategy.
6. Provides effective Quality Management leadership to department staff and to the Holdrege Leadership to meet quality, business, and organization objectives to the Company Medical: Diabetes care business unit.
7. Provides effective leadership in teamwork development, effective communication, and quick responses to Customers. Drives continuous improvement in customer satisfaction.
8. Implements effective CAPA process focused on reduction of causes of customer complaints, non-conformances and rejections.
9. Assesses and builds organization capability for Quality Management, particularly in the section and mentoring of dedicated high performer individuals.
10. Evaluates, facilities, designs, implements, and continually improves quality systems and business process including product controls to achieve quality goals and to maintain a high level of regulatory compliance.
11. Appropriately evaluates the regulatory and Quality management competencies and capabilities.
- Four-year college degree (BA or BS) preferably in the Science or Engineering discipline. Advance degree in the engineering, business, or related field preferable
- Broad background in applied statistics process controls, Six sigma is desired.
- 7+ Years relevant experience on manufacturing of medical devices
Why join us?
A career at our company means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
This company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
For additional details regarding submission eligibility and payment terms, please refer to your contract. Only submissions from agencies with current service contracts in place will be considered.
Security Clearance Required: No
Visa Candidate Considered: No