Senior Quality Manager

Orchid Orthopedic Solutions; Bridgeport Charter Township (MI); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Comprehensive benefit package

Integrity First

Teamwork

Results

Job summary

The Quality Manager at Orchid Orthopedic Solutions ensures compliance and progress toward quality goals by developing and enforcing standards and best practices. They communicate customer expectations and regulatory requirements and report to the Quality Director.

The role leads a quality culture, coaches teams, partners with leaders to achieve objectives, and drives Lean initiatives to build a compliant yet agile Quality System across the organization.

Qualifications

• Bachelor’s degree is required; a Master’s degree is preferred.
• Experience in a leadership role in manufacturing and in a regulated FDA environment preferred.
• CMQ/OE certification is a plus.

Responsibilities

• Promote a quality culture and engage the organization.
• Coach teams and drive continual improvement through problem solving.
• Develop and deliver quality objectives and partner with leadership to meet business goals.
• Drive a compliant yet agile Quality System using Lean principles.

Skills

Attention to Detail

Change Leadership

Communication

Data Analysis Tools

Decision Making

Inspection Knowledge

Manufacturing Industry

Organization

Power BI

Standard Operating Procedures

Leadership

Problem Solving

Education

Bachelor's degree

Master's degree

CMQ/OE Certification

Job description

A BRIEF OVERVIEW

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.

WHAT YOU WILL DO

• 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.

EDUCATION QUALIFICATIONS

• Bachelor (Required)
• Master (Preferred)

EXPERIENCE QUALIFICATIONS

• 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)
• Experience in an FDA regulated environment (Preferred)
• 10+ Years of Quality Leadership Experience in a Regulated Environment (Preferred)

LICENSES AND CERTIFICATIONS

• Certified Manager of Quality/Organizational Excellence (CMQ/OE) - American Society for Quality (ASQ) (Preferred)

KNOWLEDGE & SKILLS THAT ENABLE SUCCESS

• 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
• Power BI - Basic Knowledge
• Standard Operating Procedures - Extensive Experience
• Leadership - Extensive ExperienceProblem Solving - Extensive Experience

PHYSICAL DEMANDS

• 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

WHAT WE OFFER

• Opportunity to work in a growing company
• Ability to help people live a longer, more active life
• Comprehensive benefit package
• Ability to work in an organization that values:
  • Integrity First: We do the right thing
  • Teamwork: We are one Orchid
  • Results: Our results matter

At Orchid, we fully support a diverse and inclusive workplace and we are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, color, religion, sex, sexual orientation, gender identity, national origin, hair type, age, status as a protected veteran, or disability.

Candidates offered employment may be required to submit to a pre‑employment background check and pre‑employment drug‑screening based on position requirements. Applicants must be authorized to work for any employer in the United States. We are unable to sponsor or take over sponsorship of an employment visa at this time. Candidates must be able to provide proof of eligibility to work in the United States through eVerify.