Quality Engineer

Michigan, Grand Rapids-Muskegon-

Posted: 09/17/2018 Industry: Engineering Job Number: 11310 Pay Rate: $75,000.00

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.

* 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
* Participates in IQ/OQ/PQ 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 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 policies, practices and procedures
* Maintains effective working relationships, communications and feedback with all other departments
* Performs other duties as required

* BS in Engineering, Science or related field, or equivalent experience and training
* Experience in Customer-Focused Quality and/or Business Process Improvement

Job Experience:
* 3-5 Years relevant Quality Engineering experience
* Knowledge of FDA QSR, ISO13485, ISO14971 Risk Assessment desirable
* Experience in Medical Device, Healthcare or Pharmaceutical preferred, but not required

* Project Management
* Lean Manufacturing experience
* Customer Focused Quality
* Working knowledge of statistical techniques
* Working knowledge of quality and reliability software
* Ability to work in a team environment
* Working knowledge in spreadsheets, databases and word processing software programs
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