Quality Engineer

Newark, CA

Posted: 06/03/2019 Employment Type: Contract Industry: IT Job Number: JOS000008421

Job Summary: 
In this role you will work with the Director of Quality, VP of Operations and VP of Project Management to enhance and streamline the QMS to meet the needs of our growing business and the requirements of our medical device clients. This includes involvement with the management review process, internal audit process, supplier evaluations process, and calibration process, as well as working on project teams to ensure compliance with appropriate standards and regulations. 
  
Position Responsibilities: 
• Participate on project teams to meet client and regulatory requirements.  Including but not limited to: creating Quality Management Responsibilities Plans for projects; reviewing requirements and design documents to ensure those meet regulatory and quality requirements; serving as independent reviewer as necessary for formal design reviews; providing quality perspective in risk management activities; providing preliminary Regulatory Affairs input; reviewing and approving DHFs, DMRs, and DHRs for medical device projects 
• Work with Development and Operations teams to evaluate potential suppliers, including performing supplier audits as appropriate 
• Provide quality direction and oversight to designated teams for controlled builds of prototypes, devices for clinical studies, or commercial builds at a contract manufacturing site 
• Provide active support of the periodic QMS Management Reviews, including preparing data, summarizing the output of the meetings and following up with management as necessary 
• Plan, conduct and document internal audits per annual audit schedule 
• Provide guidance to internal action owners to perform corrections, root cause analysis, develop a corrective action, follow up on progress of internal actions, and perform or review verification of effectiveness 
• Work with calibration service providers and internal personnel to ensure appropriate and timely calibration of inspection, measuring and test equipment 
• Develop and conduct quality related training as required 
  
Education/Experience Requirements: 
• BA/BS Degree or equivalent in Engineering, Physical Science of Life Science 
• Minimum five years of experience 
• Strong working knowledge of FDA QSR, MDD, ISO 13485, ISO 14971,  and other related regulations and standards 
• Significant experience working in FDA regulated environment 
• ASQ Certifications are a plus (e.g., Quality Engineer, Quality Auditor, Biomedical Auditor) 
• Regulatory Affairs Certification desired 
• Proven track record working with R&D teams to support compliant design control activities 
• Experience developing and conducting quality-related training 
  
Skills & Personal Characteristics: 
• Ability to read and interpret engineering drawings in support of design control, inspection and supplier corrective action activities 
• Independent, self-starter 
• Team player 
• Strong verbal and written communication skills 
• Ability to work in a collaborative environment 
• Comfortable with electronic documentation/records systems and strong general office computing skills, including experience with creating MS Office templates 

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