Quality Coordinator

Orchid Orthopedic Solutions LLC; Farmington Hills (MI); Vor Ort; USD 52.000 - 80.000; Vollzeit

Benefits dieser Stelle

Performance bonuses

Medical benefits

401(k) with company match

Paid time off

Zusammenfassung

Orchid Orthopedic Solutions LLC in Farmington Hills, MI seeks a Quality Coordinator to ensure quality systems compliance, training completion, and document control. You will calibrate equipment, support audits, and collaborate with cross-functional teams to meet FDA guidelines and drive continuous improvement.

The role requires high school level education, 3+ years in quality-related work in regulated industries, and strong attention to detail.

Qualifikationen

• 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

Aufgaben

• Lead Document Control activities, including updating controlled documents, forms, procedures, work instructions, policies; final release of Engineering Change Orders; maintenance of document logs
• Support training programs and ensure they meet regulatory and company requirements
• Support process monitoring by conducting sample collection for production utilities (air, water, cleanline monitoring, tension testing, abrasion testing)
• Inspects parts using precision measuring equipment
• Collaborate with Sustaining Product Quality and NPI groups on quality planning such as FAR's, FIF's
• Assist the quality team on the implementation, training and use of precision measuring equipment
• Coordinate with customers when measurement system analysis is required
• Perform daily/weekly/monthly calibration of measuring equipment (excluding handheld gages)
• Advise on compliance requirements and regulations
• Track and trend quality metrics
• Assist in internal and/or customer audits
• Collaborate with suppliers on quality and process improvements
• Assist with establishing procedures/work instructions to meet FDA guidelines
• Read/interprt customer drawings to develop Quality Inspection Plans and related documents
• Participate on cross-functional project teams
• Assist engineers with part fixtures for inspection
• Work with customer and QC to determine dimensional and cosmetic acceptance criteria and methods

Ausbildung

High School Or Equivalent

Jobbeschreibung

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.