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Quality Manager

  • Job Tracking ID: 512483-747039
  • Job Location: Totowa, NJ
  • Job Level: Any
  • Level of Education: Any
  • Job Type: Full-Time/Regular
  • Date Updated: October 23, 2020
  • Years of Experience: Not Applicable
  • Starting Date: ASAP



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Job Description:

Will report to the General Manager and is directly responsible for managing and monitoring performance of all aspects of quality assurance and control at the Totowa, NJ and Manchester, NH sites. Utilizing statistical thinking and methodologies to identify opportunities, plan improvements, execute those plans, follows up to ensure business results have been statistically improved and sustained, especially with regard to meeting customer expectations. Utilizing leadership competencies to recognize and drive opportunities for improvement across all aspects of the business.

The ideal candidate will demonstrate a firm understanding of quality management systems specifically focused in the medical device field or a similarly highly regulated manufacturing environment. Expert understanding of the development and use of control plans, ISO 13485 or similar, and general quality standards and best practices are required. Additionally, candidate will have working knowledge of GLP, methods and procedures, fundamental engineering principles and their application in real-world scenarios.

This candidate will prefer a hands-on approach, and will thrive in a fast-paced, deadline-sensitive environment. The individual must be able to manage multiple simultaneous projects and be self-motivated and able to motivate others. This individual will be responsible for implementing, managing and developing all aspects of the company’s quality system.

This individual will work closely with other departments including, engineering, manufacturing, purchasing, human resources, customers, sales, consultants, regulators and external suppliers

Responsibilities:

  • Lead the implementation and improvement of the plant QMS according to ISO 13485. Maintain and manage the QMS.
  • Maintain and enforce the Quality Policy and the Quality Manual while upholding Company’s Values.
  • Evaluate business goals, identify improvement opportunities and apply scientific methods, statistics and problem-solving techniques to improve and sustain product quality and process effectiveness.
  • Plan and execute projects and team activities to facilitate changes that have a statistical impact on business results, especially as it relates to meeting and exceeding customer expectations.
  • Establish programs, policies and procedures to evaluate precision, accuracy and capability of processes, products, production equipment and testing, measurement, and analytical equipment and facilities.
  • Schedule and perform audit activities, to include pre-audit planning, audit execution and evaluation and post-audit follow-up and recommendations.
  • Assist operating units with development and implementation of corrective and preventive action plans to improve overall ISO compliance and quality results.
  • Oversee Change Management.
  • Hosting Regulatory and Customer Audits.
  • Development and administration of Quality Management System processes such as NCRs, CAPAs, calibration, validation, internal audits, complaints/RMAs, supplier management, training, document and record control.
  • Review, negotiate and execute quality agreements.
  • Develop and implement processes to ensure customer quality requirements are captured and communicated within the organization.
  • Complete customer quality surveys and support customer requests for quality/manufacturing related information.
  • Maintain risk analysis program as per ISO 14971.
  • Prepare and conduct quality system management reviews.
  • Monitor and keep management aware of the regulatory and ISO changes.
  • Maintain and update regulatory databases such as FURLS, EUDAMED etc.

Experience and Skills:

  • Strong communication, presentation, interpersonal, and organizational skills.
  • Knowledge and ability to understand and apply process audit principles (ISO/ASQ).
  • Experience in quality control program operations, to include standards & measurement techniques.
  • Ability to apply quality control theories and principles to an operational environment.
  • Must excel at working in a team environment.
  • Ability to communicate detailed, technical initiatives to non-technical people.
  • Bachelor’s degree in engineering or equivalent specialized experience.
  • 5+ years’ experience with QMS in manufacturing environment preferred.
  • Strong ISO experience - ISO 13485 preferred, other highly regulated industries considered.
  • Experience with a Toyota Production System style business system preferred.
  • Quality/statistical related certifications advantageous (ASQ, Six Sigma, CQE).
  • Strong communication skills, both written and oral.
  • Management experience with strong leadership, team-based work philosophy, daily management.

 

 

 

 

 

 

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