Quality & Validation Engineer — Medical Devices (Implants)

Kirkstall Precision; Indiana (PA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Professional development

Career progression

Collaborative culture

Impactful work

Job summary

Kirkstall Precision is seeking an experienced Quality & Validation Engineer to ensure products, processes, and equipment meet the highest quality and regulatory standards in orthopaedic instruments and implants.

The role spans IQ/OQ/PQ development, validation planning, and CAPA-driven improvements within a fast-growing precision engineering environment. Candidates should have strong analytical skills and cross-functional collaboration capabilities.

Qualifications

• Minimum 3 years’ experience in validation or quality engineering within medical devices or regulated industries.
• Experience with ISO 13485 and regulatory requirements for medical devices (FDA/MDR).
• Experience documenting URS, FAT/SAT, qualification protocols and reports.

Responsibilities

• Develop, document IQ/OQ/PQ protocols and reports.
• Plan, schedule, and perform validation activities on equipment, processes, and software.
• Lead NCR investigations and CAPA to prevent recurrence.
• Support internal, supplier, and regulatory audits and provide technical justification.

Skills

Validation engineering

Quality management

Medical devices

ISO 13485

Regulatory compliance

Statistical tools

CAPA investigations

Education

Bachelor's degree in Engineering or related field

Tools

Minitab

MSA

Job description

Kirkstall Precision is seeking an experienced Quality & Validation Engineer to ensure products, processes, and equipment meet the highest quality and regulatory standards in orthopaedic instruments and implants.

The role spans IQ/OQ/PQ development, validation planning, and CAPA-driven improvements within a fast-growing precision engineering environment. Candidates should have strong analytical skills and cross-functional collaboration capabilities.