What are the responsibilities and job description for the QUALITY MANAGER position at FXI Inc?
Overview
Building our Future Together. FXI is a leading producer of foam innovation in the Bedding, Furniture, Industrial, Home & Office, Healthcare, and Transportation markets. We have made it our mission to provide tailored solutions that delight our customers and consumers. With our corporate headquarters, high-tech research and development facility, and multiple manufacturing locations in North America, FXI has built a culture of innovation and achievement that is recognized by customers, suppliers and peers. Our products include finished goods, sub-assemblies, services, and raw materials for OEMs, fabricators, and retailers. You will find FXI’s foam innovations inside, around, and under yourself in countless applications. Everywhere foam goes, FXI’s innovations lead the way! Won’t you join us?
Responsibilities
Overview
The Quality Manager will oversee the quality operations for the San Bernardino. He/she will assure Quality oversight of all Manufacturing and Quality System activities, including those associated with Supplier management. The San Bernardino Quality Manager will plan, coordinate, and oversee the resolution of short-term issues and lead the longer term
Responsibilities
- Act as a high-level technical resource for interpretation of policy, review and approval of technical documents, and decision making related to Product Quality.
- Oversee activities involved in the review and release of raw material and finished product with a focus on compliance to company policies and industry standards.
- Provide strategy and leadership during regulatory inspections and external audits.
- Maintain Change Controls and Deviation
- Oversee Lab practices and standards.
- Review and approve all Validation Protocols and Reports.
- Conduct Quality and Continuous Improvement (Lean, Six Sigma) associate training and ensure training is current with all required company policies and practices.
- Coordinate with various departments for setting departmental procedures and devising systems for documentation requirements.
- Manage Customer Complaints.
- Revise, review, and approve SOP's, OOS's, planned and unplanned deviations, Quality Control Plans, CAPA, specifications, Batch Manufacturing Records (BMRs).
- Oversee the development of validation programs (IQ/OQ/PQ)
- Develop systems for measuring compliance with the company’s quality goals, objectives and standards. Recommend corrective action as required.
- Perform Internal Quality Audits
- Monitor Non-Compliance reports and take corrective actions to assure timely completion.
- Be the Quality Management expert, especially related to ISO 9001:2015 standards.
- Assure manufacturing of FXI products meet all requirements to assure the safety and efficacy of the product to the customer and user, and maintains a validated state.
- Oversees Investigations or CAPA activities
Qualifications
Qualifications
- Bachelor of Science (BS) degree or equivalent job experience
- 7 years’ experience in Operations, Quality and/or Engineering in a manufacturing environment.
- Demonstrated leadership with excellent verbal and written communication skills
- Lean or Six Sigma Certification (Black Belt, Green Belt, Master Black Belt or equivalent)
- ASQ CQE or CQM certification
- S in Engineering (Chemical, Mechanical, Industrial) or Technical Field (Math, Science)
- Certification as an ISO Auditor
- Prior automotive background desirable
Experience being part of inspections (FDA, EPA, Notified Body)
Key words
#LI-Onsite