Senior Quality Inspector
Tyber Medical LLC
Summary
The Senior Quality Inspector will be responsible for performing inspection on medical devices to specified requirements to determine product disposition. Will operate in accordance with company procedures, FDA Regulations, ISO 13485 and Canadian Medical Device Regulations, and other applicable requirements.
Job description
Responsibilities: Essential Duties
- Perform mechanical, visual, packaging and document Inspection of orthopedic medical devices
- Complete all required documentation of the inspection results, on handwritten forms, and electronic spreadsheets or databases, in accordance with company procedures and work instructions.
- Identify and document potentially non-conforming product.
- Ensure non-conforming product is properly segregated and quarantined.
- Interface with other departments, to address and resolve any product related issues.
- Assist with labeling of product and label reconciliation.
- Perform line clearance to ensure that product integrity is maintained.
- Read, understand, and follow company procedures and policies.
- Train new quality inspectors
Skills and Qualifications:
- Educational Requirements: High school diploma/GED (Required)
- Working knowledge of use of various gages such as calipers, micrometers, thread gages, etc.
- Knowledge of quality practices, FDA Regulations and ISO 13485.
- Knowledgeable of inspection techniques.
- Basic understand of reading engineering drawings.
- Good verbal and written communication skills.
- Strong attention to detail and accurate record keeping.
- Basic computer skills including a word processing, and spreadsheet, etc.
- Must be flexible and able to adapt to changes in priorities.
- Must be able to occasionally lift up to 25 lbs.
Requirements
- High school diploma/GED (Required)
- Working knowledge of use of various gages such as calipers, micrometers, thread gages, etc.
- Knowledge of quality practices, FDA Regulations and ISO 13485.
- Knowledgeable of inspection techniques.
- Basic understand of reading engineering drawings.
- Good verbal and written communication skills.
- Strong attention to detail and accurate record keeping.
- Basic computer skills including a word processing, and spreadsheet, etc.
- Must be flexible and able to adapt to changes in priorities.
- Must be able to occasionally lift up to 25 lbs.
Company overview
Tyber Medical LLC is a leading orthopedic device manufacturer specializing in providing rapid access to FDA-cleared and CE-marked private label orthopedic implants for the spinal, extremity, and trauma markets. Founded in 2012 and headquartered in Bethlehem, Pennsylvania, the company has established itself as an innovative Original Equipment Manufacturer (OEM) that designs, verifies, and validates full Class II orthopedic systems using QSR and ISO 13485 certified quality systems. Tyber Medical's core business model focuses on enabling orthopedic companies, stocking distributors, hospitals, and GPOs to quickly expand their portfolios with regulatory-approved implants through private labeling arrangements. The company has developed proprietary technologies including TyPEEK™ (titanium plasma sprayed PEEK) osteoconductive coatings and BioTy™ antimicrobial nano-textured surface modifications. Since its inception, Tyber Medical has successfully released more than 50 spine, extremity, and trauma systems, averaging just 12 months from signing to global launch. The company's differentiated bioengineered technologies and rapid commercialization capabilities have positioned it as a strategic partner for medical device OEMs seeking to accelerate time-to-market while maintaining rigorous quality and regulatory standards.