PDS Tech Inc Senior Supplier Development/Quality Engineer in Redmond, Washington
PDS Tech is currently seeking a Senior Supplier Development/Quality Engineer for our client in Redmond, WA
Job Summary :
Quality Engineer with duties supporting supplier development, quality management, and change management within the Quality Department.
Position Responsibilities :
Create and manage Supplier Audit Schedule. Conduct Supplier Audits.
Develop and maintain supplier qualification requirements.
Own supplier changes and lead internal cross-functional efforts.
Create supplier/component qualification plans and reports for new suppliers and supplier changes.
Knowledge of sterilization process and sterilization validation.
Review and approve component drawings and qualification plans.
Create and/or review component failure mode and effect analysis (FMEA) working with cross-functional team.
Handle Corrective and Preventive Action (CAPA) investigations.
Develop, review, provide feedback and approve quality system documentation.
Contribute to ongoing monthly quality review and quarterly Quality Management Review meetings.
Position Qualifications :
BSME or equivalent experience in a medical device environment
Five or more years relevant medical device industry experience
Sound understanding of quality assurance concepts
Full understanding of ISO 13485 and FDA 21CFR820
Ability to lead quality and supplier interaction meetings
Full understanding of part qualification processes
ASQ Certification a plus (e.g. CQA, CQIA, CQT, CQPA, CQE, etc.)
Strong communication, interpersonal and problem-solving skills with ability to work both independently and in a team environment and to present detailed technical data to internal personnel
Effective oral/written communications skills with preferences in technical writing, presentations, reports, data analysis, etc.
Experience with sterile disposable devices a plus
Proficient in analyzing product data to perform statistical and trend reporting
Proficiency with Quality tools/methodologies including: Design Control, Risk Analysis (Hazard Analysis), Design FMEA, Process FMEA, Statistical Analysis, DOE and MSA (Gauge R&R).
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.