About the Company - Our client is a leader in the Plastic Injection Molding industry specializing in Medical Device and other custom manufactured parts.

About the Role - We are currently looking for a Quality Engineer to lead development activities, including supporting part validation, qualification, and sustaining programs. This position will also act as a primary contact for customer quality concerns and supports the production and engineering departments in resolving these concerns.

Salary: $85k - $100k

Responsibilities

• Participates in the organization’s overall Stage-Gate approach to product realization.
• Has Responsibility for APQP and PPAP activities for new and changed programs as directed by the Quality & Regulatory Manager.
• Conducts training as requested and/or needed pertaining to the Quality Management System.
• Carries out Quality Planning: Process Flow Diagrams, Process FMEA, and Process Control Plan. Prepare work instructions and Inspection instructions.
• PPAP / validation for purchased materials and components.
• Pre-Launch / early containment activity implementation and reports.
• Continually improve relationships and the company’s position with customers and suppliers through direct interface and strong leadership.
• Responsibility for making disposition on material placed on-hold internally.
• Participates in the creation and management of CAPAs, SCARs, RMA activities, and sustaining programs.
• Writes and issue Quality Alerts.
• Write and perform validation protocol.
• Works collaboratively with customers and employees to provide consultation and advise on quality issues.
• Serves as primary contact for quality issues for assigned customers as based upon direction by the Quality Assurance Manager. May be required to visit customer locations as needed.

Qualifications

• B.S Degree or equivalent work experience is required.
• Valid identification and the ability to legally work in the United States.
• 4 years’ experience in a regulated manufacturing environment.
• APQP, PPAP, IQ.OQ.PQ., SPC experience preferred.
• ISO9001, ISO13485 or FDA experience preferred.
• Epicor or similar ERP experience preferred.
• Experience in print reading, cGMP/GDP, GD&T, and cosmetic specifications preferred.
• Ability to manage multiple projects concurrently.
• Excellent verbal and written communication skills with experience in Microsoft Suite.
• Experience with change control, revision change and documentation.
• Ability to manage time effectively while handling multiple projects and responsibilities.
• Ability to produce and interpret information using any of the following measures DOE, CP/CPK, Gauge R&R, FEMA, SPC, PPAP and six sigma.
• Ability to write effective and accurate reports, business correspondence, and procedure manuals; to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to lead people and get results through others; to manage a team environment effectively in the development of quality projects.
• Ability to work with mathematical concepts such as probability and statistical inference
• The position must be able to lift a minimum of 30 lbs unaided.

Pay range and compensation package - Salary: $85k - $100k