Regulatory Affairs Specialist

TE Connectivity   •  

Portland, OR

Industry: Telecommunications.

  •  

5 - 7 years

Posted 274 days ago

This job is no longer available.

Job Overview

TEGTA16

Essential Functions:

NPI Support:

  • 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.

 

Sustaining Support:

  • 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.

Qualifications

  • 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