Quality Manager - MedTech
Quality Manager - MedTech
Location: Chicopee, MA
Reporting to the Director of Quality and Regulatory Compliance with a dotted line to the Division Plant Manager, the Quality Manager – MedTech plans, directs and coordinates the development, application, and maintenance of all quality systems for inspecting incoming product, raw material, in-process material and products through finish product. Oversees and directs plans, organizes and develops test plans, prepares test data and subsequent testing of all products. Responsible for managing data during product development and evaluation prior to product release. Responsible for customer, ISO audits and for organizing compliance to regulatory requirements related to manufacturing medical devices.
Essential Duties and Responsibilities:
- Develops and documents quality plans for new and existing products.
- Monitors and controls quality systems to ensure effectiveness, efficiency and compliance.
- Analyzes quality control test results and provides feedback and interpretation to production management or staff.
- Supports manufacturing and engineering problem solving efforts on in-process and vendor related quality issues.
- Communicates quality control information to all relevant organizational departments, outside vendors and contractors.
- Investigates customer returns and complaints. Oversees development and implementation of corrective action measures to prevent re-occurrences.
- Implements procedures to assure that products comply with customer specifications.
- Coordinates, as needed, the administration of the defective material identification & disposition program; i.e., the PMDR & MRB program.
- Monitors & takes corrective/improvement action on key quality measurables; i.e., parts per million (PPM), repeat complaints.
- Performs or delegates the quality department functions defined in our APQP process.
- Assures control plans and checking methods and tools therein, are meaningful and effective.
- Provides training to manufacturing personnel to assist in the preparing definition and monitoring of quality requirements.
- Monitors existing business practices to ensure compliance with existing policies and procedures (ISO compliance).
- Serves as the quality management representative, representing the quality management system to external organizations.
- Supports product development and transfer into production to ensure process capability exists and product requirements are understood.
- Participates in conducting both internal and vendor audits; including 2nd and 3rd party quality system audits.
- Supports purchasing in supplier performance measurement.
- Oversees and directs activities of quality department staff in support and maintenance of quality systems.
- Manages individual performance providing coaching, mentoring and performance feedback to ensure that plant objectives are achieved. Instructs and mentors quality staff in quality control and analytical procedures.
- Generates and maintains quality operating budgets.
- Develops and implements quality training programs to train employees on the appropriate and necessary quality systems, techniques and methods including ISO 13485 and statistical methods.
- Produces reports regarding nonconformance of products or processes, daily production quality, root cause analyses and quality trends.
- Manages internal/external calibration of all required measurement devices, gauges and testing equipment.
- Assists other plants in assuring quality systems are in compliance, as required.
- Bachelor's degree or equivalent in quality, operations management or engineering related field.
- A minimum of 5 years experience in manufacturing with at least 2 years in a management and/or supervisory capacity.
- Depending on site location, experience in an ISO environment and ISO 9000, compliance with TS16949 and PPAP procedure.
- Certified Quality Engineer (CQE or ASQ) certificate/training a plus.
- Experience in Medical Device manufacturing required.
- Demonstrated ability implementing “world-class” quality management practices to drive continuous improvement throughout the quality systems.
Other Job-Specific Requirements:
- Excellent interpersonal and communication skills (both verbal and written).
- Strong people management and development skills.
- Strong listening skills.