DePuy Synthes is recruiting for a Calibration and Tooling Supervisor, located in Warsaw, IN.
DePuy Synthes, part of the Johnson & Johnson MedTech Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to healthcare systems worldwide. For more information, visit www.depuysynthes.com
In this role, you will also be responsible for the implementation and management of calibration activities to ensure compliance to applicable FDA regulations (i.e. 21 CFR Part 820.72) guidance documents and ISO as required.
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This role provides leadership and direction for a team of calibration technicians, toolmaker specialists, and the consumables management team at the Warsaw, IN. site. The position is responsible for ensuring the team performs within budget using best practices, innovation, and people development.
Key Responsibilities:
- In accordance with all applicable federal, state and local laws/regulations, and corporate Johnson & Johnson, procedures and guidelines, this position:
- Supervises individual contributors and is accountable for conducting effective performance management that dictate how to best utilize equipment and manufacturing techniques to streamline operational processes.
- Assists with coordination of processes and assignments for Calibration and Tooling Services area to ensure the delivery of consistent work products and process efficiency.
- Leads the implementation of new processes and procedures that strive to streamline the organization's mass production operations and applies knowledge of calibration and tooling services to devise modifications that encourage a culture of continuous improvement.
- Evaluates performance of production stages to resolve calibration and tooling services faults, equipment failures, and compliance risks in order to provide insight in the design of optimized production sequences and manufacturing operations.
- Maintains steady workflow and efficiency through implementing quality control processes and resolves operational decisions within the team.
- Responsible for managing operational aspects of their team (e.g., workflow, performance, and compliance), as well as ensuring achievement of team goals within expected standards.
- Facilitates collaboration between multi-functional teams including associate's in engineering, Product Development, Operations, etc. to drive business and organizational results.
- Assists with solving day-to-day problems, discrepancies, and investigations of non-conformances.
- Assists with and follows up on addressing internal and external audit findings making sure open action items are given appropriate priority and are addressed as needed.
- Provide calibration program guidance to ensure adequacy and consistency of calibration activities and documentation in terms of regulatory compliance and technical soundness.
- Coordination or ownership of all Calibration CAPA actions
- Responsible for communicating business related issues or opportunities to next management level
- Responsible to partner with a third-party service provider (Integrated Supplier) to manage consumable spend, savings, and issue management/resolution.
- Review and approve monthly spend/invoicing.
- Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
- Performs other duties assigned as requested by management
Qualifications
Education:
- Bachelor of Science in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related technical degree preferred.
Experience and Skills:
Required:
- Minimum of 2 years of experience in manufacturing and/or engineering is required.
- Demonstrated leadership qualities including confidence, transparency, integrity, innovation, passion, patience, and tenacity.
Preferred:
- Minimum of 2 years of experience in a supervisory or multi-functional project manager role is preferred
- Previous experience working in a regulated industry, such as Medical Device is preferred.
- Proven strong written, verbal and presentation skills.
- Demonstrated strong computer skills, such as the use of Microsoft Office, Minitab, and databases.
- Demonstrates strong organizational and project management skills
- Demonstrated troubleshooting skills.
- Strong blueprint reading abilities.
- Metrology/calibration hands on experience.
Other:
- Must be willing to support all production shifts.
- Have previous experience supervising
- Must be willing to work 100% On-site in Warsaw, IN
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.