Date Posted: December 29, 2017
Employment Type: Contract To Hire
Job Id: 8119
This individual will serve as a team member and/or leader for quality activities, including process improvements, MRB, validations, complaint investigations and internal audits. The primary work station is located in an office with some of the time spent in a cleanroom environment.
- Collaborates with supplier representatives and manufacturing engineering to maintain and improve existing products and to ensure regulatory and product performance requirements are met.
- Participates in and leads investigation of corrective actions and implements robust solution s for process/device non-conformance; monitors complaint rates and initiates improvements where required; contributes to Material Review Board; support improvement initiatives
- Develop and/or review Process Qualifications, Test Method Validations, Process Capability studies, Design of Experiment, production control plan. Review, Marketing and Product Spec Reviews, Regulatory compliance, Packaging and Sterilization
- Provide direction in implementing First Article Inspection, In-Process Inspection, Sampling Plan, product / components testing, inspection and acceptance criteria
- Writes, reviews, approves process validations/qualifications
- Conducts product complaint analysis and failure investigations.
- Analyzes process and product non-conformances and implements comprehensive corrective and preventive action plans.
- Support continuous improvement initiatives
- Lead/ participate in the Material Review Board.
- Adhere to all safety and health rules and regulations associated with this position and as directed by supervisor.
- Bachelor's degree preferred; or equivalent combination of 1 to 2 years of education
- A basic understanding of Quality Systems Regulations (QSR 21 CFR Part 820), MDD, ISO13485 is required.
- ASQ certification strongly desired.