MME Group's Quality Engineers 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.
Primary 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.
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.
Conducts training as requested and/or needed pertaining to the Quality Management System.
Other duties as assigned. Qualifications and Skill Requirements:
Valid identification and the ability to legally work in the United States.
Bachelor's Degree in a related field or equivalent work experience is required.
4 years' experience in a regulated manufacturing environment.
Embodies MME Group Core Values
We Are Customer Focused
We Execute
We Are Respectful
We Win Together
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. Benefits Include:
Medical
Dental
Vision
Life Insurance
STD/LTD
401k with match
Tuition Reimbursement
Gym Reimbursement Other details
Pay Type Salary
Min Hiring Rate $85,000.00
Max Hiring Rate $100,000.00
Required Education Bachelor's Degree