Quality Manager - Baldwyn/Tupelo
FXI has one of the largest and most diverse foam manufacturing and distribution networks in the industry. Our technology traces back to the very beginnings of the polyurethane foam manufacturing industry in the 1950s. From that springboard, we are pioneering ever greater innovations and applications for our amazing material.
Our products are inside, around and under thousands of products that you use every day. As a leading Innovator and Strategic Player in the Home, Healthcare, Electronics, Industrial, Personal Care and Transportation Markets, we offer a challenging and rewarding team-oriented work environment.
We have built a culture of innovation and achievement that is recognized by customers, suppliers and peers. Join the FXI team!
We are currently looking for a Quality Manager to join our Quality Assurance Team. This position will be responsible for managing, coordinating and administering all functions of the Quality System and Regulatory Compliance at two FXI Sites (Baldwyn and Tupelo, Mississippi), managing and implementing activities to achieve company objectives of safety, quality, efficiency, productivity, effectiveness, customer service, and regulatory compliance while sustaining a culture of continuous improvement. The ideal candidate will have strong team leadership skills, a hands-on management style and interface well with the high expectations of our customers.
- Administer the site Quality Management Systems (QMS) to ensure all elements in relationship to the plant quality system at Tupelo meet or exceed ISO 9001 requirements and at Baldwyn meet or exceed ISO 13485 and FDA Part 820 QSR (Class I) requirements.
- Coordinate the preparation for, and hosting of, external audits for ISO 9001, ISO 13485, FDA Part 820 QSR, by registration and government agencies, and customers
- Ensure all supplier, internal, and external nonconformances are tracked with measurable progress of corrective actions in a timely fashion.
- Coordinate any reporting activities to appropriate regulatory agencies.
- Produce, and report, Quality metrics and Key Process Indicators (KPI’s) as required by the QMS
- Manage receiving inspection, testing of received parts, components, materials, and products to determine conformance to standards.
- Manage internal audit programs to establish consistent adherence to all QMS and Regulatory requirements and maintain plant readiness.
- Administration of Corrective and Preventative Action (CAPA) system
- Work with engineering disciplines to develop all stages of process qualifications, IQ, OQ and PQ, along with validations, product and component test methods, inspection guidelines and quality system procedures, and participate in hazard analysis (HARM) reviews.
- Participate in supplier selection, assessment and monitoring programs
- Review and approve all elements and documents associated with Design Control and Design Transfer into Production including DHR and DMR files.
- Develop and Manage Quality Planning activities through the use of Advanced Product Quality Planning methods (APQP, PPAP, FMEA, MSA, etc) and related Core Quality Tools.
- Lead and develop a quality staff with skills and abilities to become a true service organization to support plants in training and technical troubleshooting to achieve plant and company goals and objectives.
- Develop and provide training on regulations, CGMP, QMS procedures and work instructions to employees and other stakeholders as required.
- May work on special projects/assignments upon request.
- Follow all applicable safety/housekeeping guidelines.
- Be able to lead / sponsor / manage all aspects of Continuous Improvement programs to meet defined objectives and goals.
- Ability to read, analyze and interpret journals, engineering blueprints and drawings, and governmental regulations
- Write reports and effectively present information,
- Work with mathematical concepts, solve practical and complex problems of a technical nature and deal with a variety of concrete variables in situations where only limited standardization exists.
- Lead validation process for newly developed and existing products.
- Demonstrated use of Quality tools and methodologies including experience in application and use of, DFMEA, PFMEA, HARM (Risk Analysis), Fault Tree Analysis, Root Cause and Corrective/Preventative Action.
- Practical knowledge of applied statistical tools, including process capability and Statistical Process Control.
- Utilize Continuous Improvement methodologies to define, organize, execute and properly document CI projects.
- Team player, leader, mentor and coach
- Bachelor of Science degree in an appropriate discipline
- 10 years experience in Quality Management Systems (ISO 9001, ISO 13485).
- 3 years experience with medical devices, ISO 13485 and FDA Part 820 QSR environments a plus.
- Relevant certifications (QA Mgr, Internal Auditor, etc.) from recognized organizations such as ASQ (American Society for Quality) are a plus.
- Hands on management style with experience in Six Sigma / Lean Manufacturing methodologies a Big Plus.
We offer a competitive salary and an excellent benefits package, including medical, dental and vision insurance, basic and optional life insurance, short and long term disability protection, a 401(k) plan with company match, tuition assistance, and flexible spending accounts.
FXI is an EEO employer