Senior Quality Manager

Orchid Orthopedic Solutions•Bridgeport, MI

5d•Onsite

About The Position

The Quality Manager assures compliance and progress towards the established goals of the organization and quality department by developing and enforcing quality standards and good business practices. They communicate and ensure customer expectations and regulation requirements are met. The Quality Manager reports to the Quality Director.

Requirements

Bachelor (Required)
8+ Years of experience in Quality (Required)
7+ Years of experience in a leadership role (Required)
4+ Years of experience in a leadership role in a manufacturing environment (Required)
Accuracy and Attention to Detail - Working Experience
Change Leadership - Extensive Experience
Communication - Extensive Experience
Customer Communication - Working Experience
Computer Knowledge - Working Experience
Data Analysis Tools - Extensive Experience
Decision Making and Critical Thinking - Extensive Experience
Inspection Knowledge - Working Experience
Manufacturing Industry - Extensive Experience
Organization - Working Experience
Standard Operating Procedures - Extensive Experience
Leadership - Extensive Experience
Problem Solving - Extensive Experience
Must be able to remain in a stationary position - Frequently
Must be able to move about the inside of the building - Occasionally
Must be able to communicate and exchange information with others - Constantly
Must be able to distinguish and detect information such as writing and defects - Constantly
Applicants must be authorized to work for ANY employer in the U.S.
Candidates must be able to provide proof of eligibility to work in the United States through eVerify

Nice To Haves

Master (Preferred)
Experience in an FDA regulated environment (Preferred)
10+ Years of Quality Leadership Experience in a Regulated Environment (Preferred)
Certified Manager of Quality/Organizational Excellence (CMQ/OE) - American Society for Quality (ASQ) (Preferred)
Power BI - Basic Knowledge

Responsibilities

Work positively and enthusiastically to promote a Quality culture and engage the organization.
Be a coach to your team, and develop the organization's strength through empowering the team, and driving curiosity and resilience.
Act as a leader within the business, both in developing and delivering Quality objectives, but also acting as business partner in delivering wider business goals.
Use your knowledge of regulated industry to drive a mindset of delivering compliance, whilst ensuring that this is achieved through building a depth of understanding throughout the organization, and working cross-functionally to ensure compliance is well understood and responsibilities are clear.
Engender a quality culture throughout the business, holding regular briefings with employees to continually champion the Quality cause.
Be an advocate of Lean Manufacturing and use this mindset to work alongside leadership to plan and develop the activities and priorities to develop a Quality System which is compliant, yet agile.
Promote and coach, ‘quality at the source’’ and understand the role of variation reduction and process capability in driving quality performance.
Develop the organizational competence in Problem Solving methodology and be competent in coaching Problem Solving.
Ensure the organization develops a data analysis framework and systems which supports efficient reporting, decision making and supports prioritization.