Quality Engineer

Proterial Cable America • Ashaway, RI

40d • Hybrid

About The Position

Works with engineering, manufacturing, sales, and operations in providing professional quality guidance to assess, correct, and maintain the product and process quality using statistical tools, documented methods, and audits. Works in a team environment to develop and implement best practices with emphasis on defect prevention, reduction in variation and waste, and provide for continuous improvements in meeting all customer and internal requirements.

Requirements

• Strong understanding ISO 13485:2016 Quality Management System (QMS) requirements along with basic knowledge of CFR part 820.
• Ability to fully understand customer specifications and specified standards
• Ability to follow guidelines that are common throughout the industry, maintain a constant focus on quality and accuracy, follow directions, and work with minimal supervision
• Understanding of test methods and techniques
• Experience working in an ISO 13485:2016 manufacturing environment
• Experience working in an FDA CFR part 820 manufacturing environment
• General knowledge / understanding of product and process capabilities and limitations
• Strong analytical and statistical knowledge, familiarity with Minitab Statistical Software preferred
• Strong knowledge and background in process and product validation
• Knowledge and background in software validation activities
• Experience working with ERP systems
• Proficiency in using MS Office, Internet, and e-mail.
• BS in Engineering, or related technical or scientific discipline
• 1-3 years’ experience in a medical device manufacturing environment
• Exceptional written and oral communication skills
• Good time management and workload prioritization
• Strong interpersonal skills
• Experience working in a fast-paced Manufacturing environment
• CAPA (Corrective Action / Preventive Action) Experience

Nice To Haves

• Six Sigma Training preferred

Responsibilities

• Establish and/or improve product/process quality individually through team-based problem-solving efforts using industry best practice skills.
• Participate in MRB activities and evaluate NCRs as required. Coordinate corrective action activities and complete follow-up evaluations to determine completion and effectiveness of the corrective actions.
• Manage and write process validations including but not limited to Master validation plans, PFMEA documentation, OQ/PQ protocol and OQ/PQ reports, PPAPS, FAIR, etc.
• Analyze data using industry accepted statistical methods through process validation and continuous improvement activities.
• Review and manage internal and external change control including customer specifications.
• Work with operations and ERP teams for new Route and BOM approvals through Cable Builder software.
• Facilitate software validation plans and works with the applicable team members to draft case studies, test cases and validation reports to route to management for final approval.
• Support customer complaints through root cause analysis using industry standard investigation methods.
• Support internal, customer and registrar audits as needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level