Experience a more rewarding quality career with one of the top medical device manufacturers in the world that creates a wide variety of life saving products. Imagine spending your days in a very bright, clean and climate controlled facility where you will make a greater impact on quality processes while advancing in your career.
Our client is seeking a Quality Engineer for their facility conveniently located Northwest of downtown Fort Wayne allowing you to avoid the city traffic. This is an exciting opportunity to be involved in many facets of the quality department including everything from new product launches and continuous improvement projects to customer service management.
Some of the benefits to you:
- State of the Art Facility – Get your foot in the door of a growing team that is always investing in new equipment and looking for ways to improve their processes
- Competitive compensation
- Benefits package (starting day 1) that includes: medical, dental, vision and 401(k) with company match (401k after 90 days)
- Paid time off and 10 paid holidays a year
- Adheres to Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
- Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
- Monitors manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained.
- Leads and implements various product and process improvement methodologies.
- Review the adequacy and correctness of changes to Bill of Materials (BOM’s), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
- Leads in the completion and maintenance of risk analysis.
- Leads generation and completion of protocols and reports for test method validations.
- Interfaces with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable.
- Develops various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures.
- Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.
- Effectively communicate and interact with customers.
- Leads and manage complaint investigations.
- Acts as a lead in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
- Assists with product transfers.
- Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems. Also, leads each of these groups with capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc.
- Coordinates and leads the preparation of Quality Plans, including inspection, test and gauge requirements for new product introductions
- Provides support to other quality engineers.
- Performs other functions as required.
- 80,000 sq. ft.
- 23 CNC Swiss machines; 3-, 4-, & 5-axis CNC turning centers; 3 CNC multiturret turning centers
- FDA registered; ISO 13485, CMDCAS, MDD certified
- Cellular environment
- CNC turning & milling
- Wire EDM
- Laser etching
- Laser & TIG welding
- Mass finishing
- Ultrasonic cleaning
- Rapid prototyping (metal/plastic)
About the company: With over 35 years of medical device molding experience, our client has become a comprehensive solutions provider for single use medical devices. Services range from concept and design of components to assembly of finished products. They are headquartered in Foxborough, MA and operate 17 manufacturing facilities in the US, with additional locations in China, Mexico, Costa Rica, Puerto Rico, France, Germany and the UK.
All qualified applicants will receive consideration for employment without regard to the individual's race, color, sex, national origin, religion, age, disability, genetic information, status as a military veteran or any other characteristic protected by applicable law.
- Quality engineering experience within a manufacturing environment
- Ability to read and interpret blueprints
- Quality inspection experience (GD&T)
Please click Apply or email your information to: firstname.lastname@example.org
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