Quality Assurance Engineer - Worcester MA

Job Details

  • ID#42227986
  • Address 01601 , Worcester / central MA,


    Worcester / central MA USA
  • Job type


  • Salary USD competitive competitive
  • Hiring Company

    Real Staffing

  • Showed02nd June 2022
  • Date02nd June 20222022-06-02T03:00:00-0400
  • Deadline01st August 2022
  • Category


Quality Assurance Engineer - Worcester MA

The Position: Real Staffing Group is combing the Life Science Market for an experienced Quality Assurance engineer to support processes for Medical Device development and manufacturing. The ideal Quality professional posses a high sense of urgency, a high level of energy and an exciting new perspective. This individual would have superb verbal and written communication skills and the ability to work productively on a team.

The Company: Real Staffing Group is a leader in the provision of pharmaceutical, biotechnology, healthcare, and medical devices recruitment services. With one of the largest networks of specialist recruiters in the world, we partner with companies and organizations to help manage change and deliver cost and efficiency improvements through technology, information, and people. Our premise is a simple one: by recognizing talent and valuing relationships, we can consistently deliver local, global and industry expertise to ensure success.

Responsibilities: Maintain and continually improve upon the Quality Management System ensuring compliance to 21 CFR 820, ISO 13485, EU MDR, MDSAP, and ISO 14971. Maintain the Resource Management process including continual improvement of processes (Training and Competency) ensuring all records are maintained. Maintain the CAPA process; open CAPAs, collaborate with cross-functional team to drive CAPAs through effectiveness checks and trending. Maintain the Complaint and Feedback processes; collaborate with the team to document complaints and assess reportability and trending. Contribute to the Non-Conforming Product process. Collaborate with team to document and follow through with NCRs. Responsible for establishing Material Review Board and related collaborations/meetings. Author process and test method validation plans, protocols, and reports. Plan and develop statistical studies including DOEs, T-tests, Distribution ID, process capabilities, reliability tests, Gage R&R, and other statistical tools. Authoring and/or review of Risk Management documents. Including continual improvement of processes, strategizing risk, authoring and/or review of risk management plans, risk assessment, and reports. Maintain the Management Responsibility process; responsibility for planning and executing Management Review meetings and ensuring follow through with outputs. Audits - Conduct and/or participate in internal and external audits as needed. Clean Room, Environmental Monitoring - Establish plans and ensure ongoing compliance. EO sterilization - Establish plans and ensure ongoing compliance. Authoring and/or review of D&D planning documents, product requirements documents, verification and validation plans, protocols, and reports.

Qualifications: S. degree in Engineering, Science, or related discipline required. Master's degree in engineering or MBA a plus. Minimum 7 years in a Quality role supporting Design and Development activities Minimum 7 years in a Quality role supporting a medical device manufacturing environment. Strong working knowledge of 21 CFR 820, ISO 13485, and ISO 14971. Experience developing or modifying Quality Management Systems in accordance with these regulations is desired. Good communication skills, both written and oral. Knowledge of statistical sampling and analysis Possess a high sense of urgency, good judgement, creative problem solving, initiative and common sense. Present a professional demeanor and demonstrate an ability to work effectively with a diverse group of individuals. Must be energetic, work quickly and efficiently with detail and accuracy. Must be able to effectively manage multiple priorities in a fast paced and environment.

Location: Worcester, area - Hybrid

  • Health insurance
  • 401k
  • Partial remote flexibility
  • Potential to extend

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EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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