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.