Quality Manager - Bedford, United States - Precision Coating Co., Inc.

Description

SUMMARY:

The Quality Manager is responsible for implementation of new customer processes, including design and development of production fixtures and workflow documentation.

Also responsible for process changes and enhancements that support company and customer objectives. Responsible for defining, documenting and ensuring correct and optimally efficient implementation of processes used by the company.


RESPONSIBILITIES:

• Perform Inspection Supervisor area duties
• Implement new customer processes including process transfer from development to production
• Assess customer specifications, drawings, and change orders for proper implementation
• Evaluate, define, and implement internal process changes and enhancements
• Drive new projects to completion through robust project management including management of internal and external resources
• Create, review, and refine process validation documents including IQ's, OQ's, and PQ's
• Create, review and edit process flow maps and pFMEA documents
• Create, review, and improve training instructions
• Define and develop testing methodologies for new and existing processes including QC methods
• Drive an increase in manufacturing efficiency through analysis of workflow, processes, tooling and equipment
• Troubleshoot production and workflow issues
• Collect data and provide data analysis, interpretation, and trending derived from the Inspection Access database or other data sources, including tracking of managementdefined KPI's
• Design fixtures for customer trial and processing runs
• Assist with productionrelated activities, as requested, including setup, run configuration, and certification
• Evaluate proposed trials and production jobs for the company's ability to implement them, and provide quantitative assessments of resource requirements, including labor, materials, and equipment, for input into financial cost estimate models
• Meet with customer and regulatory personnel for quality and design
• Attend periodic MEL meetings; determine root cause of quality issues and implement solutions
• Train area technicians and perform retraining as needed
• Recommend alterations to development and design to improve quality of processes and/or procedures
• Assure that the company's efforts are in full compliance with the company's quality policies, ISO and other relevant regulations.
• In Manager role, responsible for:
• Managing the workflow of department employees and delegating tasks.
• Ensures that assigned employees are equipped with the tools they need to be successful in their positions.
• Assessing the work performance of assigned employees and identifying areas that need improvement. This includes the completion of performance reviews.
• Ensure that business goals and performance standards are met.
• Maintains staff by recruiting, selecting, orienting, and training employees.

SUPERVISORY RESPONSIBILITY

• Supervises Setup/Inspection Technician group.

ESSENTIAL QUALIFICATIONS:

• Bachelor's Degree in Manufacturing, Industrial, Electrical, or Mechanical Engineering
• 3+ years in a leadership position.
• 5+ years of handon professional experience in a Medical Device manufacturing environment
• Experience in a regulated environment such as medical devices
• A collaborative mindset, a flexible and friendly approach to working in teams
• Familiarity of LEAN principles preferred
• Highly Desired Skills:
• Personnel management skills
• Strong spreadsheet/Excel skills, strong MS Word skills
• Working knowledge of ISO standards

KEY SUCCESS FACTOR
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Pay Attention to the Details: _Missing just one detail can have an enormous impact on a job. Be a fanatic about accuracy and precision. The goal is to get things right not simply to get it done. Double check your work. Get the details right the first time._
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Make Quality Personal_**:_ _Demonstrate a passion for excellence and take pride in the quality of everything you touch and everything you do. Have a healthy dislike for mediocrity. Good is not good enough. Always ask yourself, "Is this my best work?_
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Honor Commitments:_Be true to your word. Be punctual for all meetings and phone calls. If a commitment cannot be fulfilled, alert others early and agree to new deliverables._
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Get Clear On Expectations: _Create clarity and avoid misunderstandings by discussing expectations upfront. Set expectations for others and ask when you're not clear on what they expect of you. End all meetings with clarity about action items, responsibilities, and due dates._
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Deliver Legendary Service: _It's all about the experience. With every experience, do the little things, as well as the big things, that surprise people. Make every interaction stand out for its helpfulness. Create the "WOW" factor that turns customers into raving fans. This includes both internal and external customers._
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Be Relentless About Improvement: _Regularly evaluate the way you/we work to find way