Quality Manager - Bloomfield, CT

The Quality Manager plans, coordinates, and directs the activities of the Quality Assurance Program to ensure the production of consistent, reliable products that meet or exceed established standards. He / She is primarily responsible for the continuous improvement, troubleshooting, and maintenance of the QA system and is the company resource for all quality matters whether internal or external.

ESSENTIAL FUNCTIONS:

• Ensures that all subordinates understand and follow policies and procedures with regard to the quality system and/or company as they apply.
• Ensures maintenance and improvement of the quality system through routine system audits and corrective actions. Also ensures corrective actions whether internal or external are handled in a timely manner.
• Must be able to function as the site lead system auditor or quality contact for all external or third party audits.
• Plans and directs the activities of quality engineering to ensure projects are being completed on a timely basis.
• Plans and directs the activities of inspection resources with the group supervisor to ensure consistent, reliable performance and timely response to internal and external needs.
• Plans and directs the activities of site calibration resources as needed to ensure all critical inspection equipment is accurate and properly functioning.
• Primary authority for all internal & external nonconformance resolution.
• In conjunction with sales & marketing, is the primary resource and contact for external complaint resolution.
• Plans, promotes and organizes training activities related to product quality and reliability.

ADDITIONAL RESPONSIBILITIES:

• Carries out other general responsibilities as required by site management.
• Coordinate supplier audits as required.
• Participates in customer visits and acts as the company quality representative during complaint resolution at customer sites.
• Develops and analyzes statistical data, and product specifications to determine present standards and establish and propose methods to achieve customer requirements.
• Identifies new techniques, and technologies to be used in process control, inspection and calibration to improve quality, reduce inspection time and increase product throughput.
• Coordinates the preparation of automotive PPAP submissions, annual layouts, first article inspections.
• Participates as needed in product design review, new product quotes and quality planning to meet customer specifications.
• Acts as the company quality representative during regulatory audits and is responsible for ensuring adequate and timely responses to findings as a result of those audits.

KNOWLEDGE, SKILLS AND ABILITIES:

• Strong background in ISO9000 system management, including training and auditing.
• Strong background in ISO13485 system management and thorough knowledge of FDA (21CFR820) requirements and other international standards that regulate the medical device industry.
• Strong background in quality engineering, metrology, GD&T. Knowledge of automated inspection equipment including vision systems and Coordinate measuring devices.
• Strong ability to handle multiple tasks with various levels of priority; Must be able to coordinate the requirements of daily production, project engineering, sales & marketing with quality engineering and inspection services to achieve timely response to specific needs.
• Strong communication skills; must be able to present ideas, results and requirements effectively throughout the organization and to the customer on a timely basis.
• Strong Skills in applied statistics, reliability, design of experiments, MSA, GR&R and project management.
• Strong computer skills: must be familiar with various software packages commonly used in project management, database, statistical process control (SPC), word processing and data acquisition.
• Strong interpersonal skills.

TRAINING AND EXPERIENCE:

• Bachelors degree, preferably BS, BSE, BSME, with a minimum of 3 years experience in quality engineering or quality management in metal stamping, injection molding, medical device or related industry, OR an equivalent level of both background and experience.
• Certified Quality Engineer, Manager or Auditor.
• Demonstrated project management skills in the areas of process control, SPC, automotive PPAP submission and statistical analysis.
• Actively continuing training through, courses and seminars.