Senior Quality Engineer

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

A BRIEF OVERVIEW
The Senior Quality Engineer is a key technical leader who strengthens the quality and reliability of Orchid's legacy products across all sites. This role pairs deep quality expertise with cross-functional influence by partnering with critical customers, guiding engineers through validations and new product introductions, and shaping the training and standards that elevate performance. The person in this role becomes a go-to resource for problem-solving, decision support, and quality strategy, with opportunities to lead initiatives that have site-wide and cross-site impact.

WHAT YOU WILL DO

• Leads or co-leads quality initiatives that align with site and corporate quality strategies, ensuring consistent adoption and measurable improvement.

• Provides direction, coaching, and technical mentorship to engineers, inspectors, and cross-functional partners to build capability and strengthen overall quality culture.

• Acts as a key decision-maker in escalated quality situations, balancing customer expectations, compliance requirements, and operational needs.

• Supports the Quality Manager in site-level planning, audits, and strategic reviews, stepping in as a delegate when needed.

• Drives cross-functional alignment during investigations, validations, and change management activities, ensuring teams stay focused, informed, and moving toward resolution.

• Provides and documents training on standard of work instructions, policies, and procedures in a timely manner to ensure team members have the required knowledge and skills prior to performing work independently.

• Uses quality tools to implement improvements including: process flowcharting, Pareto analysis, correlation and regression analysis, significance tests, design of experiments, statistical process control, gauge repeatability and reproducibility, and trend analysis techniques

• Acts as a customer liaison and processes customer quality complaints, as applicable.

• Collects, Analyzes, and Presents data using statistical methodology

• Assists suppliers with the interpretation of quality requirements, as applicable.

• Assists the development of essential QMS deliverables/Advanced Product Quality Planning (APQP) including, but not limited to: complaint analysis, risk analysis, failure mode and effects analysis, CAPA, and process/equipment/software verification / validation

• Plans and/or conducts process and equipment validations and special validations including installation qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

• Determines machine and/or process capability through planning and/or executing Process Capability studies

• Develops inspection criteria that connect customer requirements and manufacturing processes that include identification of key characteristics, associated sampling plans, and required gauging.

• Interfaces with appropriate customer contacts to clarify customer requirements

• Conceives and/or Leads productivity improvements and/or Continuous improvement projects

• Monitors engineering production processes and products for adherence to internal and external requirements and practices.

• Participates in pre- and post-production launch reviews providing quality engineering support

• Performs quality reviews and internal audits; evaluates data and writes associated reports

• Recommends modifications to existing quality or production standards, where applicable, to achieve optimum quality within limits of equipment capability.

• Reviews and approves product/process and document change requests.

• Reviews drawings to evaluate quality requirements including: correct application of geometric dimensioning and tolerance, proper use of process and material specifications, and key characteristics for inspection plans and gauging techniques.

• Supports measuring and analyzing key metrics to monitor performance.

• Works with cross-functional teams to solve production and quality problems.

• Creates and manages the overall course structure and sets up course programs based on specifications.

  Reinforces safety expectations. Ensures safety operating practices are demonstrated. Reports issues/concerns to Supervisor.

• Support quality and compliance by adhering to all procedures, work instructions, and forms per the Quality Management Systems (QMS).

EDUCATION QUALIFICATIONS

• Bachelor of Science (B.S) (Required)
• Master of Science (M.S) (Preferred)

EXPERIENCE QUALIFICATIONS

• 5+ Years of Experience (Required)
• 5+ Years of Experience in a Manufacturing Environment (Preferred)
• Experience in Medical Device Manufacturing (Preferred)
• Experience leading a team (Preferred)
• Experience managing change in a complex environment (Preferred)

LICENSES AND CERTIFICATIONS

• Any Quality Certification (Preferred)

KNOWLEDGE & SKILLS THAT ENABLE SUCCESS

• Operational Functions - Extensive Experience
• Quality Management - Extensive Experience
• Process Management - Working Experience
• Communication - Working Experience
• Accuracy and Attention to Detail - Working Experience
• Manufacturing Safety - Extensive Experience
• Lean Manufacturing - Working Experience
• Statistical Analysis and Measurement - Working Experience
• Production Part Approval Process (PPAP) - Working Experience
• Production Runs - Extensive Experience
• Final Inspection - Working Experience
• Computer Knowledge - Working Experience
• Customer Communication - Working Experience
• QSR and ISO - Extensive Experience
• Coaching - Working Experience
• Information Processing - Working Experience
• Lean Assessment - Extensive Experience
• Problem Solving - Working 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 move equipment around the building - Rarely
• Must be able to ascend/descend stairs or ladders - Rarely
• Must be able to position oneself and move under/around/over equipment - Rarely
• Must be able to handle/adjust/inspect/position various items and equipment - Rarely
• Must be able to communicate and exchange information with others - Constantly
• Must be able to perform tasks that require repetitive handling/adjusting/inspecting/positioning of items and equipment - Occasionally
• Must be able to distinguish and detect information such as writing and defects - Constantly

WORKING CONDITIONS

• Noise - Occasionally

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.