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Manager, Quality Assurance

3 months ago

Chaska, Minnesota, United States Integer Holdings Full time

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.

At Integer, our values are embedded in everything we do.

Customer

We focus on our customers' success

Innovation

We create better solutions

Collaboration

We create success together

Inclusion

We always interact with others respectfully

Candor

We are open and honest with one another

Integrity

We do the right things and do things right

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.

Key Accountabilities and Responsibilities:

  • Adheres to Integer'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, Company policies and operating procedures, and other regulatory requirements.
  • Maintains safe and ethical business practices and adheres to GB's Quality Policy.
  • Manages the Quality Team to meet Site/BCT/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 and BCT 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.
  • 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.

Job Requirements:

Minimum Education: Bachelor's Degree in related field Minimum Experience: 5-8 years of related experience in quality and personnel/supervisory positions.

Specialized Knowledge: ISO 13485, ISO 9001, 21 CFR 820, Special Skills: Collaborative, Task Driven, Team Player, Self Starter Other: ASQ Certifications, optional

U.S. Applicants: EOE/AA Disability/Veteran

Equal Opportunity Employer, including Disability/Veterans