Quality Control Manager

Atrium Medical   •  

Merrimack, NH

Industry: Healthcare

  •  

8 - 10 years

Posted 176 days ago

This job is no longer available.

Job Function Summary:

To oversee all Quality Control functions at incoming, in-process, and final inspection phases to ensure business objectives are achieved.  Manage, develop and train QC Technicians in a multi-shift GMP operation.

Job Functions

  • Management and development of Quality Control department, consisting of 30+ employees across three shifts.
  • Ensures proper resourcing of Quality Control department including equipment and personnel.
  • Accountable for all business objectives and goals and quality performance metrics in compliance with company and regulatory standards.
  • Define and implement training programs to ensure all technicians understand and comply with quality standards for all products.
  • Utilize Lean, and 5S methodology to develop process and programs to realize efficiencies, effectiveness and cost savings.
  • Assists in initiating NCRs and coordinating Material Review Boards to determine final disposition as needed.
  • Assists with confirming sterility release and the disposition of quarantined product.
  • Maintains Quality Control DHRs for all product lines.
  • Provides input for QC inspection techniques to assist in establishing efficient and effective methods for evaluating component parts.
  • Reviews and Approves Engineering Change Orders / pilot shop orders / rework procedures as needed.
  • Ensures proper execution and release of holds, including ship holds.
  • Contributes to team effort by accomplishing related duties as requested.

Required Knowledge, Skills and Abilities: 

  • Demonstrated leadership, people development and team building skills.
  • Strong interpersonal and communication skills with creative problem solving ability. 
  • Requires prior management experience.
  • Inspection and measurement experience is preferred.
  • Proficient in Microsoft Office applications (Word, Excel, PowerPoint).
  • Experience working in a highly matrixed, GMP manufacturing setting.
  • Knowledge of Lean, 5S or Six Sigma, with demonstrated results in cost savings and increased efficiencies.

Minimum Requirements:  

  • Bachelor's degree or equivalent work experience. 
  • A minimum of seven years of management experience in medical device or pharmaceutical manufacturing is required. 

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