Senior Quality Manager
Role Overview
At Orchid Orthopedic Solutions, we're more than just a contract manufacturer of orthopedic devices; we're on a mission to enable a longer, active life. With a dedicated focus on implants, instruments, and groundbreaking technologies, we serve a range of dynamic markets, including joint reconstruction, spine, trauma, sports medicine, extremities, and dental. Our manufacturing facility, nestled in the vibrant community of Bridgeport, MI, spans 85,000 square feet and specializes in cutting tools for orthopedic, dental, and trauma applications. Our product lineup boasts burs, pins, screws, drills, reamers, and saw blades, all meticulously designed to meet the highest quality standards for both implants and instruments.
A career at Orchid is more than just a job; it's an opportunity to grow. We offer a comprehensive benefits package that includes performance bonuses, insurance coverage, a 401(k) plan with a company match, paid time off, and engaging employee events. But it's not just about the perks; it's about being part of a team that values growth, innovation, and excellence.
SHIFT
No Shift ($0) (United States of America)
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 (Preferred)
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 Experience
Problem 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
Key Skills for This Role
Full Job Posting
ABOUT US
At Orchid Orthopedic Solutions, we're more than just a contract manufacturer of orthopedic devices; we're on a mission to enable a longer, active life. With a dedicated focus on implants, instruments, and groundbreaking technologies, we serve a range of dynamic markets, including joint reconstruction, spine, trauma, sports medicine, extremities, and dental. Our manufacturing facility, nestled in the vibrant community of Bridgeport, MI, spans 85,000 square feet and specializes in cutting tools for orthopedic, dental, and trauma applications. Our product lineup boasts burs, pins, screws, drills, reamers, and saw blades, all meticulously designed to meet the highest quality standards for both implants and instruments.
A career at Orchid is more than just a job; it's an opportunity to grow. We offer a comprehensive benefits package that includes performance bonuses, insurance coverage, a 401(k) plan with a company match, paid time off, and engaging employee events. But it's not just about the perks; it's about being part of a team that values growth, innovation, and excellence.
SHIFT
No Shift ($0) (United States of America)
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 (Preferred)
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 Experience
Problem 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
ADDITIONAL REQUIREMENTS
- 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 U.S. 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
- 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.
- Orchid Orthopedic Solutions only pays fees for solicited presentations of job seekers submitted through our preferred vendor job board by recruiters, employment agencies, or other parties.
- 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)
- LICENSES AND CERTIFICATIONS
- 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 Experience
- Problem 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
- KNOWLEDGE & SKILLS THAT ENABLE SUCCESS
Preferred Qualifications
- 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)
- Orchid Orthopedic Solutions only pays fees for solicited presentations of job seekers submitted through our preferred vendor job board by recruiters, employment agencies, or other parties.
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.
- Bachelor (Preferred)
- Master (Preferred)
About Orchid Orthopedic Solutions
Manufactures orthopedic implants and instruments for medical device companies.
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