Quality Engineer

Essential Functions

• Facilitate standardized inspection and sample size methodology based on risk, process capability.
• New product involvement.
• Inspection reduction based on process, production, or feature inspection issues for existing product.
• Interact with In-process Inspection and Final Inspection, issue identification and resolution.
• MRB member, determine conformity of suspect parts.
• Identifying failure modes and enacting countermeasures.
• Audit quality processes and inspection methods.
• Involvement in CAPA’s, Quality Alerts, Retraining and data collection as needed.
• Oversight of CMM programming schedule as directed.
• Participation in project management as needed.
• Conform to ISO13485, 21 CFR Part 820, and medical device industry requirements.
• Other work-related tasks as assigned.

Competencies

• Mastery in Process Capability, lean inspection methodology.
• Strong emphasis on understanding of GD+T.
• Strong understanding of statistical analysis.
• Prowess in problem-solving.
• Respectful and positive attitude.
• Strong computer skills (MS Office).

Education and Experience

• High School Diploma or GED preferred.
• Minimum 3-5 years of Medical Device experience in Quality setting preferred.

Benefits

• Medical, Vision and Dental Insurance.
• Short-Term Disability.
• Life Insurance.
• 401(k) - 50% company match (up to 10% contribution).
• Paid vacation days.
• Paid holidays.