SUMMARY OF POSITION: Responsible for meeting customer requirements for the approval of surgical instruments and/or implants through the PPAP (Production Part Approval Process). The position will participate as a team member with a key customer facilitating activities between the supply and Paragon Medical.
EXPERIENCE: Experience with tight tolerance measurement systems and methods in machining applications, blueprint reading, GD&T, and a working knowledge of short run process control methods, DOE, ISO standards and FDA quality system regulations. Previous orthopaedic experience preferred. Bachelor degree in Business, Mechanical/Biomedical engineering or related field; willing to consider relevant experience in combination with education in lieu of degree. Previous supervisory experience in medical device manufacturing preferred. Windows-based computer knowledge required.
SKILLS: Excellent interpersonal, problem solving and communication skills. Individual is able to work with minimal supervision and actively participate in a team oriented, continuous improvement, manufacturing environment. Premier organizational skills and attention to detail required. Strong leadership, ability to handle multiple tasks and prioritize in a fast-paced environment. Strong problem-solving, decision-making and process improvement skills.
- Practical implementation and monitoring of systems and procedures for meeting ISO standards and FDA quality system regulations.
- Specify required inspection equipment and holding apparatus to accommodate repeatable measurements, including Gage R&R studies, etc. and associated reporting.
- Assist company Lean/6 Sigma initiatives to remove variability & reduce cost. This position is also responsible for ensuring cell processes are correctly base-lined & controlled. Known variability is to be accounted for through selection & frequency of inspection, sampling plans, or implementation of SPC.
- Lead or assist in leading multi-function continuous improvement activities.
- Represent Paragon Medical in meeting with Customers to fully develop their requirements or as required in the manufacture of contracted products.
- Lead the PPAP process to transfer medical devices between suppliers in support of departmental and overall company goals.
- Work with processes and procedures to develop and execute PPAPs and supporting documents including PFMEA’s, control plans, validations, etc.
- Work proactively with the team to share best-practices, and lessons learned.
- Track and report process metrics to ensure effective and efficient transfer of product between suppliers and plants and drive continuous improvement and performance to the department.
- Foster close and productive relationships with cross-functional counterparts to facilitate the rapid closure of project requirements.
- Acquire, develop, and expand clients’ partnerships with Paragon Project management
- Understand project schedules for all projects that are within the department.
- Work with other functional areas (i.e. Sales, Purchasing, Manufacturing and customer) to obtain whatever cooperation, agreement, resolution or assistance as required to bring closure to product transfers for Paragon Medical’s global facilities, correctly, within the budget and on time.
- Integrate with the Business Development to maintain alignment of overall business strategies and long-term goals.
Paragon Medical, Inc. - 19 months ago