Quality Manager

Position Summary

Leads the Quality function at the Teleflex Medical OEM Jaffrey NH manufacturing facility, ensuring robust, complaint, and efficient delivery on quality and regulatory requirements, through all phases of Customer, product and process lifecycle of Components and Assemblies for the Medical Device Industry.
Manage the development and maintenance of all plant quality systems, ensuring that necessary regulatory and corporate compliance systems are in place and adhered to. This position serves as the Management Representative for the Jaffrey facility. Position is based in Jaffrey NH.

Principal Responsibilities

Driving QMS and Customer Quality requirements throughout product and process lifecycle including NPI, Commercialization, post release feedback and support, Sustaining and End of Life.

Managing and developing the Quality team to assure consistent application of quality standards and regulatory compliance, audit readiness and Customer satisfaction.  

Collaborates closely with Plant, Manufacturing and Engineering leadership, to drive operational efficiency while fostering a culture of quality delivery, customer focus, accountability and continuous improvement..

Implementation and maintenance of Quality Management System (QMS) requirements including product realisation and release processes, Supplier quality, external and Internal Audits, Complaint handling, Nonconformances and CAPA investigations, document control, risk management, and change control processes.

Principal Resposnsabilities

• Develop quality systems and establish procedures in compliance to FDA regulations and ISO requirements
• Establish and implement compliance training programs.
• Ensure all manufacturing processes are verified or validated, monitored, and maintained in a state of control, meeting requirements under Customer requirements, FDA 21 CFR 820, ISO 13485, and other applicable regulations.
• Develop and monitor and analyze  key performance indicators (KPIs) for quality execution and support Customer Satisfaction driving Continuous Process Improvement.
• Champion a Quality culture of Customer focus, and proactively identifying and implementing process improvements and quality best practices across the VS Work on assigned projects with limited supervision
• Represent Quality for new and existing product improvement, manufacturing transfers, and quality plan initiatives. Support protocol, procedure and specification development
• Complete special assignments as assigned by your Manager
• Generally operate with appreciable latitude for actions or decisions on day-to-day activities; receive guidance on novel or controversial problems
• Outline and implement improvements to Quality System, and processes

Education / Experience Requirements

•    B.S. Degree in Engineering, Physical Science, Life Sciences, or a related technical field.
•    Minimum of 5 years’ medical device industry experience
•    Minimum of 5 years’ related quality experience in a manufacturing environment

•    Minimum of 3 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 textiles, 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. database 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 blueprints, 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 

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