Viant 620 Watson Street Southwest, Grand Rapids, MI 49504, USA
Apr 17, 2019Full time
Viant , a leading manufacturer of medical devices, is looking for a Quality Engineer to join their Grand Rapids, MI team. Under the direction of Quality Management, the Quality Engineer, with dotted line responsibility to the Operations Manager, supports the launch and sustaining production of Class I and II Medical Devices. The Quality Engineer assures Value Stream activities remain in compliance with FDA/ ISO regulations/ standards/ guidelines, facility SOPs and Policies, and customer requirements, supporting organizational Quality/ Business Goals and Objectives while providing team leadership support for process improvement projects, namely quality and productivity increases, and cost and scrap reductions. Some of the benefits to you: 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 holidays Greater stability – Viant recently doubled in size and is investing heavily in their facilities Facility Highlights: 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 Capabilities: Finished goods assembly Flexible production: low/high volume On-site ETO sterilization services Complete packaging design services 4 dedicated packaging engineers Position Qualifications: BS in Engineering, Science or related field, or equivalent experience and training Experience in Customer-Focused Quality and/or Business Process Improvement 3+ Years relevant Quality Engineering experience Please click Apply or email your information to: firstname.lastname@example.org Responsibilities: Continuously reviews methods, procedures, processes, etc. to determine improvements related to quality and cost to reduce scrap and increase efficiencies, makes recommendations upon approval, implements and motivates subordinates to recommend improvements Independently leads problem-solving efforts, including customer complaint investigations and analysis to identify and resolve sporadic and chronic quality issues to ensure production of safe and effective medical devices Ensures related findings and documentation are completed in a timely manner and in compliance with FDA standards and procedures and recommends actions or changes to improve Quality Assists in writing Quality Assurance nonconformance reports; reviews nonconformance reports developed by staff; provides feedback to management on results, provides solutions and recommendations when applicable; recommends studies and analysis to solve nonconformance and Quality problems Initiates writing necessary documents needed for product launch such as MVP Master Validation Plan and Component Risk Protocol Initiates writing necessary documents needed for TMVs Test Method Validation Initiates writing necessary documents needed for component and in-process device inspections Participates in IQ/OQ/PQ/PV activities including the drafting or review of protocols and reports, PFMEAs and other risk analysis documents, qualifies, validates production processes Independently performs machine and process capability and performance studies; recommends and, upon approval, leads and implements changes and upgrades to systems, procedures and processes to improve product Quality Assesses compliance with applicable regulations within the manufacturing processes and recommends improvements to ensure that safe and effective products are produced Provides written reports and supporting documentation of compliance and for recommendations Trains Quality Assurance Inspectors and manufacturing personnel in understanding specifications, new product audits, procedures, environmental controls, and requests training or training support Leads or participates in internal/external Quality System audits Assists in the assessment of Viant’s Supplier Development Program; addresses problems and recommends solutions to supplier quality; interfaces as necessary to ensure product specifications are met Reviews potential changes to products in production for reliability impact to aid in the correction process, design or material problems Follows and assures that personnel comply with FDA Quality Systems Regulation, ISO Standards and SOP’s as defined by Viant’s policies, practices and procedures Maintains effective working relationships, communications and feedback with all other departments Performs other duties as require 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.