Quality Coordinator

Orchid MPS Holdings, LLC; Farmington Hills (MI); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Performance bonuses

Medical benefits

401(k) with company match

Paid time off

Job summary

Orchid Orthopedic Solutions in Farmington Hills, MI is seeking a Quality Coordinator to manage document control, training support, and calibration of inspection equipment. This role supports ongoing QA activities and collaborates with cross-functional teams to ensure FDA compliance and ISO 9001 adherence.

The position requires 3+ years in quality systems within regulated industries, attention to detail, and strong analytical skills.

Qualifications

• Experience in quality-related work is required.
• 3+ years of quality systems experience in a highly regulated industry.
• Basic knowledge of ISO 9001 and FDA guidelines is preferred.

Responsibilities

• Lead document control, updating forms, procedures, work instructions and logs.
• Support training programs and regulatory/compliance needs.
• Calibrate and inspect measurement equipment and support QA/NPI reviews.
• Read customer drawings to develop inspection plans and coordinate with QC.
• Assist with internal and customer audits and supplier quality initiatives.

Skills

Accuracy and Attention to Detail

Data Analysis Tools

ISO 9001 Knowledge

Organization

Computer Knowledge

Education

High School Or Equivalent

Job description

Combining Strengths. Expanding Possibilities. Tecomet and Orchid are now one company. Explore more at www.tecomet.com.ABOUT USThe 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.SHIFTDET - Shift 1 ($0) (United States of America - Michigan)A BRIEF OVERVIEWThe 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 DOLead 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 logsSupport 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 testingInspects parts using precision measuring equipmentWorks with the Sustaining Product Quality and NPI group as required on the review and/or implementation of Quality planning such as FAR’s, FIF’sAssist the quality team on the implementation, training and use of precision measuring equipmentWorks with customers when measurement system analysis is requiredPerforms daily, weekly, and monthly calibration of all measuring equipment other than handheld gagesAdvises all team members on compliance requirements and regulationsTracks and trends quality metricsAssists in internal and/or customer auditsWork with suppliers on quality improvement and process improvementAssists with establishing procedures, work instructions, etc. that meet FDA guidelinesRead 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 customerEDUCATION QUALIFICATIONSHigh School Or Equivalent (Required)EXPERIENCE QUALIFICATIONSExperience 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 SUCCESSAccuracy and Attention to Detail - Working ExperienceData Analysis Tools - Working ExperienceISO 9001 (Quality Management) - Basic KnowledgeOrganization - Basic KnowledgeComputer Knowledge - Working ExperiencePHYSICAL DEMANDSMust be able to remain in a stationary position - FrequentlyMust be able to move about the inside of the building - OccasionallyMust be able to distinguish and detect information such as writing and defects - ConstantlyWHAT WE OFFEROpportunity to work in a growing companyAbility to help people live a longer, more active lifeComprehensive benefit packageAbility to work in an organization that values:Integrity First: We do the right thingTeamwork: We are one OrchidResults: Our results matterADDITIONAL REQUIREMENTSCandidates offered employment may be required to submit to a pre-employment background check and pre-employment drug-screening based on position requirementsApplicants 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 timeCandidates must be able to provide proof of eligibility to work in the United States through eVerifyAt 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.