Quality Engineer

iMPact Business Group

Grand Rapids, MI

JOB DETAILS
HEADQUARTERS
Grand Rapids, MI, US
LOCATION
Grand Rapids, MI
POSTED
30+ days ago
Our medical device manufacturing client in the Greater Grand Rapids area is looking for a sharp Quality Engineer for direct hire.
This position will involve:
  • Follow and comply with FDA Quality Systems Regulations, ISO Standards and SOPs as defined by our clients policies and procedures.
  • Continuously reviews methods, procedures, processes, etc. to determine improvements related to quality and cost to reduce scrap and increase efficiencies, implements and motivates co-workers to recommend improvements
  • Independently leads problem-solving efforts, including customer complaint investigations and analysis to identify and resolve sporadic and chronic quality issues in a timely manner to ensure production of safe and effective medical devices
  • Assists in writing nonconformance reports; reviews nonconformance reports initiated 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 and provides support in execution
  • 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, assists in qualification, validation of 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
  • 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 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
  • Maintains effective working relationships, communications and feedback with all other departments
  • Bachelors of Science in Engineering, Science or related field, or equivalent experience and training
  • Knowledge of FDA QSR, ISO13485, ISO14971 Risk Assessment desirable
  • 3-5 Years relevant Quality Engineering experience
  • Experience in Medical Device, Healthcare or Pharmaceutical preferred, but not required
  • Experience in Customer-Focused Quality and/or Business Process Improvement
  • Bachelors of Science in Engineering, Science or related field, or equivalent experience and training
  • Knowledge of FDA QSR, ISO13485, ISO14971 Risk Assessment desirable
  • 3-5 Years relevant Quality Engineering experience
  • Experience in Medical Device, Healthcare or Pharmaceutical preferred, but not required
  • Experience in Customer-Focused Quality and/or Business Process Improvement

About the Company

iMPact Business Group

Working with iMPact

 

Here at iMPact we have helped connect candidates to opportunities available in Information Technology, Accounting/Finance, Engineering, and Business Process/Administration. We have full-time, part-time and contract positions available in Michigan, Florida as well as nationwide.

 

Our headquarters is located in Grand Rapids, MI and we also have an office in Tampa, FL. When you’re working with us, one of our experienced recruiters will connect you with matching opportunities and they will be there every step of the way to help you through the application, interviewing and onboarding process to ensure success.

 

To connect with one of our recruiters, submit your application for one of our open positions, or visit our website www.impactbusinessgroup.com to submit your resume for general consideration. We look forward to hearing from you!

COMPANY SIZE
100 to 499 employees
INDUSTRY
Staffing/Employment Agencies
EMPLOYEE BENEFITS
Medical, Dental and Vision
FOUNDED
2004
WEBSITE
https://impactbusinessgroup.com