Quality Manager - Ogden, Utah United States - 40870



JOB DESCRIPTION

Job #: 40870
Title: Quality Manager
Job Location: Ogden, Utah - United States
Employment Type:
Salary: contact recruiter for details
Other Compensation: 5%-7% bonus based on company performance
Employer Will Recruit From: Local
Relocation Paid?: NO

WHY IS THIS A GREAT OPPORTUNITY?


Very stable company, very old and well respected in the Medical Device Industry.

Their plant is growing very quickly with new business coming all the time. In April they plant did over $2 million in one month.

JOB DESCRIPTION

Quality Manager

Salt Lake City, UT

 

The Quality Manager is responsible for managing and implementing the Quality Management System and processes across the Business Unit (BU).  This position oversees Quality Assurance and Regulatory Compliance at the BU-level, and ensures cross-functional Quality Management System (QMS) deployment for both product and process compliance. 

 

The Quality Manager (QM) supervises and guides team members following performance management practices and policies.  The QM also assures the consistent quality of production by developing and enforcing Good Manufacturing/Documentation Practice (GMP/GDP), process validation, quality inspection, and employee training.

 

Responsibilities:

 

Responsible for developing and maintaining the BU QMS, in compliance to all prevailing regulatory standards (e.g., FDA, ISO, etc.)

 

Monitors the effectiveness of the QMS, and drives continuous improvement and maintenance of the system

 

Communicates effectively with management

 

Serves as the Quality Management Representative of the BU, acting as the primary contact with regulatory agencies and customer quality personnel

 

Hosts all customer, 3rd-party regulatory, and internal audits, and provides a response to all observations, findings, and minor/major non-conformances

 

Aligns the BU-level QMS with the long-term strategic vision and initiatives, as directed by the VP Quality and senior management team

 

Accomplishes the Quality Department human resource objectives by recruiting, selecting, orienting, training, scheduling, coaching, counseling, and disciplining employees; communicates job expectations, and leads team in talent and performance management processes

 

Manages the Document Control function, including document creation, update, and release, as well as all related change review and implementation

 

Responsible for understanding customer needs and requirements, and converting them into effective quality control processes

 

Identifies product and process quality trends, and reports on the status and management of non-conformances and corrective/preventive action (CAPA) activities

 

Leads all internal and external non-conformance and corrective/preventive action activities (NCR/CAPA’s), including investigation, containment, root cause analysis, and resolution

 

Ensures that all products/processes maintain their state of validation and that all changes are effectively implemented and communicated

 

Assures the reliability and consistency of production, through incoming, in-process, and outgoing inspection and control processes

 

Ensures that formal lot release is performed through a rigorous review of Production Device History Records (DHR’s)

 

Maintains the BU state of equipment calibration, as well as control of all associated records

 

Collaborates with Purchasing Department in Supplier Quality Management, including supplier selection, evaluation, and ongoing surveillance (e.g., score card ratings)

 

Ensures that all SOP’s and related process documentation are created in accordance with the BU QMS, and works with all departments to ensure their effectiveness

 

Provide resources, support, ideas, and recommendations to facilitate a “Culture of Quality”

 

Updates job knowledge by studying trends and developments in Quality Management, pursues educational opportunities, reads professional publications, and participates in professional organizations and networking activities

 

Demonstrates all the Corporate Values:

  • We have an engaging culture.
  • We embrace the rigor to be safety and quality-driven in all that we do.
  • We embrace our choice to work here.
  • We operate with transparency, ethics, and integrity.
  • We consistently meet our expectations.
  • We encourage innovation.

QUALIFICATIONS

Education and Experience:

 

Bachelor’s degree in a STEM field, engineering degree preferable

 

10 years + professional, experienced in Quality Management Systems with progressive scope and responsibility; medical device experience *preferable*

 

Required Skills:

 

Motivational leader, team management, and implementation skills

 

Strong project management skills and experience

 

Regulated QMS background (e.g., ISO or FDA); Certified Lead Auditor or similar certificate a plus

 

Strong background with Pre-Production QA, including PFMEA, GR&R, Control Plans, and Process Validation

 

Detail-oriented and thorough

 

Strong decision-making ability

 

Energetic, and goal-oriented

 

Excellent communicator (written, oral, and presentation skills)

 

Excellent analytical, problem-solving, and facilitation skills

 

Ability to work well under pressure and in a complex environment

Strong work ethic

Proficient in Microsoft Office applications

 

Willing to travel overseas and domestically, on occasion

Education:
University - Bachelor's Degree/3-4 Year Degree

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