Supplier Quality Engineer - Medical Device - Ayer, MA
An opportunity to work in an OEM Medical Device Environment.
This company inspires their employees to strive beyond industry standards.
About Our Client
Our client is a mid size OEM Medical Device manufacturer. They develop and manufacture an FDA approved medical device capital equipment used to save lives! They are in need of a hands-on Quality Assurance & Compliance Engineer with quality assurance and compliance experience to support an on-going initiative.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
- CAPA - Conduct failure investigations, root-cause analysis, and corrective action implementation. Provides leadership and technical expertise for effective Root Cause Analysis
- ISO 13485, ISO9001
- Develop and implement quality improvement with working knowledge of Quality standards and systems.
- Support Manufacturing Lean initiatives & be a hands-on engineer.
- Ability to be hands-on quality advocate for the brand
- Work cross functionally with other in-house departments & contract manufacturers
- Knowledge of production and process controls in a regulated industry
- Experienced in compliance
- Experience in test plan development and root cause failure analysis and working knowledge of supplier quality management
- Experience with post-market initiatives
- Supply Chain experience
- Excellent communication skills - including written technical reports.
The Successful Applicant
- Bachelor's Degree in Engineering REQUIRED
- Minimum of 3 years quality assurance & compliance experience
- Strong verbal and written communication skills and customer facing experience
- Must have experience with supplier quality engineering
- Must have experience with SCARs, Root Cause Analysis, CAPAs and PPAP
- Familiarity with regulatory compliance forms
What's on Offer
- Competitive compensation package
- Opportunity to work for a fast pace and innovative life saving product
- Great health benefits