The Quality Manager is responsible for managing the plant quality program; ensuring products meet customer requirements, continually improving processes, maintaining compliance to FDA, QSR, and ISO quality standards.
- Plans, organizes, leads and controls the quality function for the plant to ensure customer satisfaction.
- Develops/maintains procedures for product testing to ensure reliability, durability, manufacturability and safety of finished products.
- Tracks quality performance of plant; non-conformance reports (NCRs), reworks, customer complaints, delivery, analyze trends and work with production to determine and implement corrective actions, report quality data for management review. Works with customers and production in addressing quality questions / problems, providing recommendations, establishing and monitoring corrective actions.
- Coordinate with Compliance: internal audits per established schedule to evaluate location's compliance; external audits by customers, FDA and ISO. Acts as management representative for FDA and ISO-13485 inspections.
- Develop and implement corrective actions to address non-conformances identified by audits.
- Participates in selection, sourcing, and implementation of new equipment/processes with suppliers and internal functions (Purchasing, Engineering, Design, etc.).
- Studies specifications and confers with Engineering and shop personnel to resolve design problems related to material characteristics, dimensional tolerances, service requirements, manufacturing procedures and costs.
- Insures that calibration schedules and QC procedures are established and followed.
- Develops / reviews / revises quality system procedures and SOPs as necessary.
- Ensure that all required training is identified for and completed by all direct reports.
- Evaluate staffing needs and costs; identifies, hires and promotes individuals with the right skills and competencies necessary to achieve superior results.
- Develop a team environment that values diversity and uses various individual’s strengths to the benefit of the team.
- Additional responsibilities as requested or required.
- Bachelor’s degree or equivalent experience.
- Minimum 3 years of experience working in a medical device industry.
- 1-3 years minimum management experience with managing direct reports
- Knowledge, including practical application of FDA QSR, ISO 13485 Standard Regulations
- Strong communication, analytical, organizational and management skills
- Proficiency with MS Office, Oracle and Quality Systems software
- Knowledgeable with Process validation, IQ, OQ, PQ and with developing inspection plans, process control plans and DFMEA/PFMEA’s
- High ethical standards and integrity.
An Equal Opportunity/Affirmative Action Employer –M/F/Disabled/Vet