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Viant
Quality Assurance ManagerViant • Brimfield, MA, United States
Quality Assurance Manager

Quality Assurance Manager

Viant • Brimfield, MA, United States
30+ days ago
Job type
  • Full-time
Job description

Quality Manager

At Viant, we partner and innovate with our customers to provide the highest quality, life enhancing medical devices in the world.

As Quality Manager, the primary purpose of this job is responsibility for the planning, and management of a Quality Engineering Group, which includes Quality Engineering and Quality Assurance.

Essential duties and responsibilities:

  • Adheres to Viant's values and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, ISO Standards, Company policies and operating procedures, and other regulatory requirements.
  • Maintains safe and ethical business practices and adheres to Viant's Quality Policy.
  • Manages the Quality Team to meet Site & Organizational goals and customer expectations.
  • Collaborates with cross functional organizations to facilitate successful execution of lean initiatives, production plans and Product Development Process.
  • Oversees, coordinates and supports the Continuous Improvements, Control Plans, Quality Plans and Validations using statistical methods relevant to manufacturing processes.
  • Provides ongoing metrics communications and support to Plant Management toward attainment of objectives. Performs corrective & preventive actions so that the customers' needs are satisfied; directs, plans and implements a comprehensive quality system designed to improve product quality and increase customer satisfaction.
  • Performs and coordinates qualification activities in accordance with internal processes and to the intent of the Master Validation Process.
  • Manages subordinates in a manner that fosters a self-directed and collaborative team approach.
  • Coordinates and provides training and mentoring for Quality Improvements to enhance Associate skills, increase awareness and improve productivity.
  • Assists in the development and implementation of Quality Objectives.
  • Participates and/or Leads Project Teams for the implementation of Enterprise and Site Quality Objectives.
  • Supports and Maintains alignment of Site QMS Documents with QMS Enterprise Policies.
  • Serves as the Management Representative.
  • Hosts internal and external audits including Notified Body (ISO), Customer and FDA.
  • Interviews, hires, and establishes training plans for direct reports.
  • Provides leadership regarding development of individuals' goals and mentoring of the group.
  • Performs other functions as required.

The successful candidate will possess:

  • 5+ years of experience in a regulated industry (Medical - Aerospace - Automotive)
  • 5+ years of Quality Management leadership experience
  • Bachelor's degree or related experience required
  • Extensive experience with FDA, ISO-13485, ISO-9001 and other relevant regulations.
  • Experience within a contract or OEM manufacturing (Preferred)
  • Proven track record of successful regulatory audits and compliance.
  • Demonstrated experience leading and interacting with customers and suppliers.
  • Demonstrated experience leading high-functioning teams and driving continuous improvement using Lean Six Sigma methodologies.
  • Exceptional communication and interpersonal skills.
  • Strong problem-solving abilities and decision-making skills.
  • Results-oriented with a track record of achieving key performance indicators (KPIs).

Benefits:

  • Medical, dental, and vision benefits-effective date of hire!
  • Company-paid life insurance and disability benefits
  • Generous Paid time off and 10 paid Holidays
  • 401k Plan with Company Match
  • Tuition Reimbursement
  • Voluntary Universal Life and Long-Term Care
  • Voluntary Legal Plan
  • Pet Insurance
  • Home Ownership Program
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Quality Assurance Manager • Brimfield, MA, United States

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