- Establish process metrics to evaluate process performance, define control points, and work with engineering, and manufacturing to ensure that product specifications and expectations are met.
- Support process validation studies for special processes to improve TE-Medical's quality assurance methodology. Support development of Product Validation Plans, IQ/OQ/PQ protocols, and Test Measurement Validations.
- Draft and execute design of experiments (DOE) and capability studies.
- Work as a part of a core team with Development and Manufacturing Engineering as required in new product introduction. Contribute to all new product deliverables, including Design and Process FMEA, Control Plans, etc.
- Support the new product develop processes to assure product meets customer requirements.
- Provide leadership to and be a capable resource for the development of and execution of statistical process control (and appropriate related methods).
- Support and manage the verification system at TE Medical for new and existing products.
- Develop standard quality inspection procedures and methods.
- Implement process controls related to Finished Medical Device packaging, labelling and sterile product management; including aspects such as label reconciliation, segregation and material flow controls, and lot release activities.
- Provide sterility assurance support for the administration of sterilization supply chain qualification and maintenance.
- Qualify sterilization and cleaning processes that comply with FDA and customer requirements.
- Establish quality system documentation required for the qualification/ implementation and maintenance of sterilization processes and sterile product release as they pertain to compliance per applicable external standards/regulations.
- Resolve any special quality, test, and certification requirements in cooperation with engineering and assure overall agreement between TE Medical and customer drawings and specifications.
- Create Quality Inspection Plans for components and assembly.
- Work to affect Cost of Quality improvement projects.
- Work with Manufacturing Engineering in the day-to-day identification & resolution of production issues.
- Drive to resolve product return and customer complaint issues.
- Support First Article inspection program, process capability studies, and inspectionaudits to verify quality levels for problem part numbers.
- Site related external audit support as it pertains to sterilization.
- Promote compliance to company procedures.
- Five or more years of experience in regulatory
- BS degree in science, engineering, or manufacturing.
- Demonstrated expertise in quality concepts, practices and procedures.
- Strong interpersonal skills are required.
- Ability to plan, establish and coordinate test and inspection procedures, conduct process capability studies, prepare statistical quality control data and develop statistically designed experiments
- Working knowledge of FDA 21 CFR Part 820 and ISO 13485 are required.
- Knowledgeable of medical device sterilization - ideally Ethelene Oxide or Gamma Sterilization).
- Maintains expertise regarding the requirements of all applicable external standards that pertain to medical device sterilization process validation.
- Experience in customer and regulatory audits is preferred.
- Prior experience with finished medical devices is required.
- Validation experience with sterile medical devices is required.
- Ability to travel as required.
Requisition ID: 22972