Quality Engineer

PLYMOUTH, Minnesota
Jan 26, 2017
Feb 26, 2017
Employment Status
Full Time
Ware has partnered with growing company that is in need of a Quality Engineer! This is a 6 month contract-to-hire scenario. The Quality Assurance Engineer is accountable for ensuring compliance with regulatory requirements and implementation of an effective quality management system.  ESSENTIAL DUTIES AND RESPONSIBILITIES: -Ensures compliance with applicable regulatory standards and requirements, as well as, compliance with the quality system manual, quality policy, and all applicable work instructions. -Complies with, administers, maintains, and provides data to QA operating systems including but not limited to: Internal and supplier corrective/preventive action system, Complaint system, Internal audit system, Control of non-conforming items system, Calibration system, Product quality plans, Receiving inspection and final testing systems, and Quality management system reviews. -Administers and maintains CAPA/SCAR and complaint systems and acts as the CAPA coordinator. -Coordinates and oversees failure analysis investigations for complaints, interacting with Technical Support, Service and Production groups, as well as, suppliers. -Administers and maintains the MRB and system and acts as MRB and RMA coordinator. -Leads/coordinates internal auditing function. -Maintains databases used for quality trending, performs trend analysis, and ensures implementation of appropriate corrective/preventive actions. -Ensures designs meet stated technical objectives by performing risk analysis, evaluating test results, and recommending alternative designs/test procedures and protocols. -Creates product test/design verification/validation plans, performs test verification/validation plans, and analyzes results. -Supports product line manufacturing and design stages by reviewing documents and determining the need for testing and/or verification/validation. -Performs risk analysis and risk management tasks as needed. KNOWLEDGE, SKILLS AND ABILITY REQUIRED FOR POSITION: -Bachelor’s degree in engineering, quality technology or equivalent. -2+ years related experience in a regulated environment, preferably medical device. -Familiarity with associated product regulatory standards and requirements such as cGMP/QSR/ISO 13485/CMDCAS/MDD/etc. -Exhibits care and strong attention to detail. -Ability to communicate effectively both written and orally. -Basic understanding of statistics and statistical process control preferred. -Must have the ability to effectively problem-solve, think clearly and positively in high-pressure, time-sensitive situations. -Able to interface effectively with suppliers and optimize the cost of quality. -Ability to read, understand and train to manufacturing drawings, technical procedures, and government regulations.   Desired Qualifications: -Certifications:  CQE, CQA, CQM or CRE. -Training in auditing per ISO and FDA requirements. -Experience with medical devices, process validation, design review, supplier quality, customer complaints, returns from customers, notification to certification entities and the FDA, and leading or participating in audits performed by certification entities or the FDA. -Preparing and filing of regulatory submissions with the FDA, technical files for CE markings, and other regulatory submissions such as MHW or CSA.