QC Inspector

QC Inspector at Orchid Orthopedic Solutions summary:

QC Inspector responsible for reviewing Device History Records, inspection paperwork, and Certificates of Conformity to ensure compliance with regulatory and customer requirements for orthopedic implant manufacturing. Performs visual, dimensional and functional inspections using handheld metrology tools, conducts first article/receiving/in-process/final inspections, quarantines nonconforming material, and records inspection data per QMS/GMP. Trains inspection personnel, escalates issues to Quality Engineering, and supports KPIs for quality, safety, and on-time delivery on 2nd shift.

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 .

SHIFT

A BRIEF OVERVIEW
The QC Inspector, DHR reviews paperwork to ensure all paperwork for manufactured product meets federal regulations. This position reports to the QC Supervisor.

*This position is for 2nd Shift (2PM - 10:30 PM)

WHAT YOU WILL DO

• Verifies all Certificate of Conformity.

• Closes travelers and scans them into the filing system.

• Redacts travelers when requested.

• Lead quality and compliance by utilizing One Orchid global processes and complying with all Quality Management Systems (QMS) documentation requirements and establishing/supporting plan(s) to meet/exceed Key Performance Indicators (KPIs) for Quality that support Safety, Compliance, Six Sigma Quality, On-Time Delivery (OTD) and financial objectives.

• Ensure compliance to Orchid requirements in inspection and record keeping. Collect inspection data and report results.

• Maintain accurate documentation at all times during the manufacturing and inspection process per Good Manufacturing Practices.

• Perform complete Device History Record review including inspection documentation

• Ensure all raw materials received meet specifications.

• Perform testing and inspection at various stages of production, including visual and dimensional inspection

• Ensure customer specifications and other applicable internal external requirements are followed.

• Use handheld inspection tools for measurement purposes, such as micrometers, calipers, height gages, optical comparator, gage blocks, and dial indicators.

• Conduct physical inspection of product with gauging such as: Thread gages, plug gages, pin gages, functional gages.

• Perform visual and/or cosmetic inspection of product following applicable procedure(s) using appropriate light sources. Monitor equipment to ensure proper operation and escalate any equipment-related issues.

• Communicate potential nonconforming situations to Quality Engineering and Quality Management.

• Demonstrate an understanding of basic manufacturing concepts and processes.

• Quarantine non-conforming or potential non-conforming parts or materials.

• Work modified schedules to support production requirements as necessary.

• Complete First Article Inspections as well as receiving, in-process, and final and packaging inspections against customer requirements with minimal supervision

• Train inspection personnel.

• Inspect customer-returned parts

• Under guidance, perform first piece inspections to support production and perform internal manufactured first articles.

• Advocate for the health and safety of self, co-workers, customers, and the community.

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

• Complete all required training.

EDUCATION QUALIFICATIONS

• High School Or Equivalent (Required)

EXPERIENCE QUALIFICATIONS

• No previous work experience required

• Experience in a Scientific Field (Preferred)

• Experience in Quality Inspection and Lean Manufacturing (Preferred)

• Experience in document review (Preferred)

• Medical Device or other regulated industry experience (Preferred)

• 1+ Year of Experience Inspecting Parts (Preferred)

LICENSES AND CERTIFICATIONS

• Any Technical Trade School (Preferred)

• Any American Society for Quality (Preferred)

KNOWLEDGE & SKILLS THAT ENABLE SUCCESS

• Mathematical Ability - Working Experience

• Data Entry - Working Experience

• Computer Knowledge - Working Experience

• Communication - Working Experience

• Collaboration - Working Experience

• Handwriting - Working Experience

• Accuracy and Attention to Detail - Working Experience

• Quality Inspection Metrology Tools - Working Experience

• Information Processing - Working Experience

• Blueprint Reading - Working Experience

• GD&T - Working Experience

• Visual Quality Assurance - Working Experience

• Layout Inspection - Working Experience

• Time management - Working 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 - Occasionally

• Must be able to position oneself and move under/around/over equipment - Occasionally

• Must be able to handle/adjust/inspect/position various items and equipment - Constantly

• Must be able to communicate and exchange information with others - Frequently

• Must be able to perform tasks that require repetitive handling/adjusting/inspecting/positioning of items and equipment - Constantly

• 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.

Keywords:

quality control inspector, medical device inspection, Device History Record, GMP QMS, first article inspection, metrology tools, dimensional inspection, nonconforming material quarantine, certificate of conformity, GD&T blueprint reading