Quality Coordinator

Orchid; Detroit (MI); On-site; USD 52,000 - 68,000; Full time

Job summary

Orchid, a growing orthopedics company in Farmington Hills, MI, seeks a Quality Coordinator to maintain quality systems and ensure regulatory compliance. The role emphasizes document control, training support, and calibration activities within a highly regulated medical devices environment.

The ideal candidate has a high school diploma or equivalent, 3+ years in quality systems, and familiarity with FDA guidelines.

Qualifications

• High school diploma or equivalent required.
• Experience in quality-related work required.
• 3+ years in quality systems in regulated industries preferred.
• Knowledge of FDA guidelines and quality systems.

Responsibilities

• Lead Document Control activities, updating controlled documents and release of Engineering Change Orders.
• Support training programs to meet regulatory and company requirements.
• Assist calibration and inspection activities with precision measuring equipment.
• Coordinate quality planning with FARs, FIFs, and quality initiatives.
• Support measurement system analysis with customers as needed.
• Assist internal and supplier audits and non-conformity investigations.

Skills

Attention to detail

Data analysis

ISO 9001 knowledge

Organization

Computer skills

Education

High School Diploma or Equivalent

Job description

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

ABOUT US

The Farmington Hills, MI site was established in 2005. Our 50,000 square foot facility employs approximately 150 team members. Our site focuses primarily on plasma spray coating (HA, TPS) in the spine and large joint for orthopedic implants that enable a longer, active life. A career with Orchid provides growth opportunities, a great benefits package including performance bonuses, medical benefits, 401(k) with company match, and paid time off. For more information, please visit www.orchid-ortho.com.

SHIFT

DET - Shift 1 ($0) (United States of America - Michigan)

A BRIEF OVERVIEW
The Quality Coordinator is responsible for a variety of activities to ensure quality and compliance needs are met. S/he is responsible for maintaining quality systems, ensuring training is performed and recorded as required, coordinating documentation maintenance and change control, ensuring monitoring, measuring and test equipment is calibrated as required, process monitoring, supporting continuous improvement initiatives, and compliance adherence.

WHAT YOU WILL DO

• • Lead Document Control activities, including but not limited to updating controlled documents including Forms, Procedures, Work Instructions, Policies and Documents, final release of Engineering Change Orders, maintenance of document logs
  • Support training programs and ensure they meet all applicable regulatory and company requirements.
  • Supporting process monitoring by conducting sample collection for production utilities, including but not limited to, compressed air system, water system, cleanline monitoring, tension testing, abrasion testing
  • Inspects parts using precision measuring equipment
  • Works with the Sustaining Product Quality and NPI group as required on the review and/or implementation of Quality planning such as FAR’s, FIF’s
  • Assist the quality team on the implementation, training and use of precision measuring equipment
  • Works with customers when measurement system analysis is required
  • Performs daily, weekly, and monthly calibration of all measuring equipment other than handheld gages
  • Advises all team members on compliance requirements and regulations
  • Tracks and trends quality metrics
  • Assists in internal and/or customer audits
  • Work with suppliers on quality improvement and process improvement
  • Assists with establishing procedures, work instructions, etc. that meet FDA guidelines
  • Read and interpret customer drawings and specifications to develop and maintain Quality Inspection Plan and other documents that are part of the Orchid Quality System.
  • Participate on cross-functional new and legacy project teams.
  • Assist engineers with the conceptualization and development of part fixtures to hold parts during inspection.
  • Work with customer and QC to determine customer dimensional and cosmetic acceptance criteria and inspection methods where they are not clearly defined by the customer

EDUCATION QUALIFICATIONS

• High School Or Equivalent (Required)

EXPERIENCE QUALIFICATIONS

• Experience in Quality-Related Work (Required)
• 3+ Years of experience with quality systems in a highly regulated industry (i.e. Medical Devices, Aerospace, Pharmaceutical, Food, or Nuclear) (Preferred)

KNOWLEDGE & SKILLS THAT ENABLE SUCCESS

• Accuracy and Attention to Detail - Working Experience
• Data Analysis Tools - Working Experience
• ISO 9001 (Quality Management) - Basic Knowledge
• Organization - Basic Knowledge
• Computer Knowledge - 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 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.