Viant, a leading manufacturer of medical devices, is looking for a Supplier Quality Engineer for their Grand Rapids, MI facility. This is a critical role that acts as the primary contact with suppliers on all quality related issues. You will be responsible for all supplier management activities, interactions, and continuous improvement initiatives.
Some of the benefits to you:
- Competitive compensation
- Benefits package that includes: medical, dental, vision and 401(k) with company match
- Paid time off and holidays
- Greater stability – Viant recently doubled in size and is investing heavily in their facilities
- 209,000 sq. ft. campus, 3 facilities
- Class 7 & 8 clean rooms
- FDA registered, ISO certified 11135, ISO 11607, ISO 13485, EN 550, cGMP compliant
- Finished goods assembly
- Flexible production: low/high volume
- On-site ETO sterilization services
- Complete packaging design services
- 4 dedicated packaging engineers
- BS in Engineering or related field or equivalent in experience and training
- 3+ years of experience in Customer Focused Quality and/or Business Process Improvement
- Knowledge of FDA QSR, ISO13485 and ISO14971 Risk Assessment
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- Follow and ensure personnel comply with FDA Quality Systems Regulation, ISO Standards and SOPs as defined by Viant Medical’s policies and procedures.
- Authorizes Quality Department approval signature for Change Orders
- Ensures that all record keeping and documentation is completed in a timely manner according to established policies and procedures
- Develops and recommends plans, programs and policies required to meet established objectives and industry standards
- Assists suppliers in Qualification/Validation activities for production/manufacturing processes Continuously reviews methods, procedures, processes, etc. to determine improvements related to quality and cost to increase efficiencies
- Motivates peers to recommend improvements
- Independently performs process capability and performance studies with suppliers; recommends and, upon approval, assists suppliers with implementation of changes and upgrades to systems, procedures and processes to improve product quality
- Independently leads problem-solving efforts with suppliers, including customer complaint investigation and analysis to identify and resolve sporadic and chronic quality issues to ensure production of safe and effective medical devices
- Ensures that documentation and findings are completed in a timely manner and in compliance with FDA standards and procedures and recommends actions or changes to improve quality
- Assesses compliance with applicable regulations within the manufacturing processes and recommend improvements to ensure suppliers provide safe and effective products
- Provides written reports and supporting documentation of compliance and for recommendations
- Requests training or training support as needed Leads Supplier Quality System audits
- Participates in internal audits. Responsible for maintaining Approved Supplier List Responsible for reporting, follow-up, and closure of supplier SCARs
- Assembles presentations on supplier issues and metrics for management reviews
- Maintains effective working relations, communications, and feedback with all internal and external customers.
- Performs other duties as required
About the company: With over 35 years of medical device molding experience, Viant, formerly known as MedPlast, 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.