Senior Quality Manager

Orchid; Bridgeport (CT); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Comprehensive benefits

Growth opportunities

401(k) company match

Job summary

Orchid Orthopedic Solutions in Bridgeport, MI, seeks a Quality Manager to ensure compliance with quality standards and drive continuous improvement. The role reports to the Quality Director and champions a data-driven approach across the organization.

You will lead a cross-functional team in a regulated manufacturing environment, shaping the Quality System and partnering with leadership to meet strategic objectives. A CMQ/OE certification is preferred and prior FDA-regulated experience is a plus.

Qualifications

• 8+ years of experience in Quality
• 7+ years in a leadership role
• 4+ years leading in a manufacturing environment
• Experience in FDA regulated environments preferred
• 10+ years of quality leadership in regulated settings preferred

Responsibilities

• Promote a Quality culture and engage the organization.
• Coach and develop the team to strengthen organizational capabilities.
• Lead quality objectives and act as a business partner for broader goals.
• Drive compliance while building cross-functional understanding of responsibilities.
• Engender a quality culture with regular employee briefings.
• Advocate Lean Manufacturing to develop a compliant yet agile Quality System.
• Promote quality at the source and reduce variation and improve process capability.
• Develop organizational competence in Problem Solving and coaching.
• Ensure data analysis framework supports reporting and decision making.

Skills

Quality Management

Lean Manufacturing

Regulatory Compliance

Data Analysis

Leadership

Problem Solving

Communication

Quality Assurance

SOPs

Team Building

Education

Bachelor (Preferred)

Master (Preferred)

Tools

Power BI

Job description

Combining Strengths. Expanding Possibilities. Tecomet and Orchid are now one company. Explore more at www.tecomet.com.

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.