Quality Manager

ob Description PRINCIPAL RESPONSIBILITIES Management and development of Quality team members to ensure that key quality system processes (CAPA/NC, Calibration, Audits, Quality engineering, complaint handling) are staffed with qualified personnel that are appropriately trained and ensure adequate resources are available for assigned tasks. Lead and manage the development and deployment of the facilities' quality system that meets corporate objectives in compliance with FDA and ISO regulations and requirements. Outline and implement improvements toQuality System and processes as needed. Provide Quality team support of enterprise excellence culture by promoting Lean Manufacturing practices and supporting achievement of annual site objectives. Lead the facility in the implementation and maintenance of ISO 13485 Quality System certification including MDSAP. Lead and direct regulatory audits including FDA, Notified Body, and Corporate audits. Serve as the facility management representative. Develop and sustain the supplier control and quality management process assuring a stable supply chain. Lead the Quality Engineering and Quality staff to drive Value Stream activities including CAPA, NC and Validation efforts. Responsible for the CAPA and NCR corrective action programs Increase efficiency of quality systems processes. Ensure all Risk Management activities are executed and maintained according to all regulatory standards Lead the document control system Represent Quality for new and existing product development, manufacturing transfers and quality plan initiatives. Support protocol, procedure and specification development. Generally operate with appreciable latitude for actions or decisions on day-to-day activities; receive guidance on novel or controversial problems. Develop and foster strong relationships with key stakeholders within the facility and Teleflex. Build interdependent relationships with R&D, Marketing, and RA and Administration. Work on assigned projects, including corporate projects, with limited supervision. Develop and foster strong relationships with key opinion leaders within Teleflex. Job TitleQuality ManagerOpportunity POSITION SUMMARY Supervise and manage the development and maintenance of all plant quality systems including supplier development, calibration, internal auditing, CAPA, quality engineering, production support efforts including validation/testing in the Chelmsford facility. Work with Post Market Surveillance team to address/manage complaints. Establish and implement compliance training programs. Ensure that necessary regulatory corporate compliance systems are in place and adhered to. Represent quality for new product development and provide statistical support as needed throughout the plant. This position is based in Chelmsford, MA. Requirements EDUCATION / EXPERIENCE REQUIREMENTS B.S. Degree in Engineering, Physical Science or similar. Masters Degree or MBA preferred. Minimum of 3 years medical device industry experience Minimum of 5 years related quality experience in a manufacturing environment Minimum of 2 years experience supervisory or management experience ASQ CQA or CQE certification preferred Broad engineering experience in manufacturing operations including new product development, cost reduction, and quality engineering Knowledge in clean room controls, medical device development and device assembly desirable  SPECIALIZED SKILLS & OTHER REQUIREMENTS Strong leadership and management skills Demonstrated experience in mentoring and coaching others Regulatory, cGMP, QSR, knowledge base Statistical knowledge (DOE, SPC, hypothesis testing, sample comparison) Strong computer skills (i.e. data-base development, statistical software and analysis, word processing for report generation, etc.) Strong negotiation and problem solving skills Ability to operate and communicate effectively with multiple teams Supplier auditing knowledge and ability (i.e. ASQ-CQA, internal/external courses, seminars) Able to understand blue prints, tolerance analysis and related knowledge Strong reasoning/analytical skills including the ability to support and prioritize projects and adapt to shifting priorities Work with minimal supervision Able to successfully resolve problems and conflicts  TRAVEL REQUIRED: Up to 10% #18-7101
Salary Range: NA
Minimum Qualification
5 - 7 years

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