Position Title
Quality Manager - Plymouth, MN
SBU
OEM
Department
Quality Assurance
Relocation Covered
NO
Educational Requirements
Bachelor's degree
Experience Requirements
Demonstrated leadership and management skills in a faced paced manufacturing environment;
Hands on Regulatory knowledge i.e. QSR, ISO 13485;
Demonstrated statistical application (DOE, SPC, hypothesis testing, sample comparison);
Computer literate (i.e. , statistical software and analysis, word processing for report generation, etc.);
Negotiation and problem solving skills;
Ability to operate and communicate effectively with multiple teams;
Able to understand blue prints, tolerance analysis and related knowledge;
Reasoning ability, support and prioritize projects, adapt to shifting priorities, work with minimal supervision, able to resolve problems and conflicts.
Qualification Reuirements
B.S. degree in Engineering (industrial, mechanical, chemical, etc.);
7-10 years related experience;
ASQ CQM or CQE required;
Broad engineering experience in medical device manufacturing (i.e extrusion, manual/machine assembly), including new product development, cost reduction, and quality engineering.
Preferred Qualifications
n/a
Responsibilities
Provide leadership to the plant quality group while supervising and managing the development and maintenance of all plant quality systems including, but not limited to, supplier management and development, calibration, internal auditing, NC’s, CAPA, quality engineering, production support efforts including validation/testing. Manage OEM complaint handling. Establish and implement compliance training programs. Ensure that necessary regulatory compliance systems are in place and adhered to. Represent quality for new product development and provide statistical support as needed throughout the plant.
MAJOR DUTIES AND RESPONSIBILITIES:
Develop quality systems and establish procedures in compliance to FDA regulations and ISO requirements. Manage quality system metrics for operational status and identification of improvement opportunities.;
Management the development of staff; ensuring that the entire quality system is resourced with appropriate personnel to maintain operational effectiveness of, but not limited to, inspection, CAPA, supplier management, calibration system, quality engineering, and complaint management.;
Establish quality goals and objectives aligned with Teleflex corporate including performance management objectives for all direct reports.;
Act as Management Representative and responsible for conducting management reviews.;
Represent QA for new and existing product improvements; support protocol, procedure and specification development.;
Direct customer contact related to quality matters including managing customer audits. ;
Represent Quality for new and existing product improvement, manufacturing transfers, and quality plan initiatives. Support protocol, procedure and specification development.;
Works on assigned projects with limited supervision including special assignments as assigned by the Director of QA;
Works as a team member of the plant management staff and interacts with all plant functions up to and including executive management staff. Generally operates with appreciable latitude for actions or decisions on day-to-day activities; receives guidance on novel or controversial problems as necessary.
