Quality & Validation Engineer

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

Medical Device Precision Engineering - Orthopaedic Instruments & Implants

We are looking for an experienced Quality & Validation Engineer to join our fast-growing precision engineering business specialising in orthopaedic instruments and implants. You will play a central role in ensuring that products, processes, and equipment consistently meet the highest standards of quality, safety, and regulatory compliance.

This position suits a technically capable engineer with excellent attention to detail, and someone motivated to drive improvements across both quality and validation disciplines within a dynamic and growing medical device organisation.

Inspection department at Kirkstall Precision

Key Responsibilities

Validation

• Develop, execute, and document IQ/OQ/PQ protocols and reports in accordance with regulatory, customer, and internal quality requirements.
• Plan, schedule, and perform validation activities across equipment, processes, test methods, and software systems.
• Creation of User Requirement Specifications (URS) and validation protocols and reports.
• Apply appropriate statistical tools (e.g., Minitab) to analyse data and support validation conclusions.
• Support the introduction and qualification of new equipment, tooling, fixtures, quality inspection and manufacturing processes.

Quality Engineer

• Support and maintain the Quality Management System (QMS) in accordance with ISO 13485, including document control, change control, and continuous improvement of quality processes.
• Lead and support nonconformance (NCR) investigations, ensuring accurate documentation, timely resolution, and effective corrective actions.
• Conduct root cause analysis and drive implementation of CAPA to prevent recurrence of quality issues.
• Participate in internal audits, supplier audits, and external regulatory audits, preparing documentation and providing technical justification where required.
• Support incoming inspection, in-process quality checks, and final product release activities when needed.
• Perform gauge R&R studies, measurement system analysis (MSA), and ensure continued suitability of inspection methods.
• Assist in supplier quality activities, including qualification, performance monitoring, and investigation of supplier-related nonconformities.
• Support creation and review of quality plans, control plans, first article inspection (FAI) documentation, and product verification plans.
• Monitor and report quality metrics (e.g., scrap, yield, NCR trends) and contribute to data-driven improvement initiatives.

Risk Management

• Conduct and support FMEA and risk assessments across products, processes, and equipment.
• Ensure risk control measures are implemented, verified, and maintained in line with regulatory expectations.
• Support ongoing product and process risk reviews throughout the lifecycle.

Cross-Functional Collaboration

• Work closely with Senior Management, Production Engineers, Operations, and Finishing teams to ensure alignment on quality and validation requirements.
• Provide technical guidance on quality best practices, validation planning, and regulatory expectations.
• Troubleshoot quality or process issues, supporting teams with problem-solving and robust engineering solutions.

Skills & Experience Required

• Minimum 3 years’ experience in validation or quality engineering within medical devices, implants, precision engineering, or other regulated industries.
• Strong working knowledge of ISO 13485, QMS principles, and regulatory requirements for medical devices (MDD/MDR/FDA).
• Experience with validation documentation including URS, FAT/SAT, equipment qualification, and software validation.
• Competent with statistical tools, data analysis, and problem-solving methodologies.
• Skilled in FMEA, risk management, root cause analysis, and quality engineering tools (5 Whys, Fishbone, 8D, DMAIC).
• Experience supporting internal audits, CAPA investigations, NCR management, or supplier quality activities.
• Degree-qualified in Engineering, Science, or relevant discipline (or equivalent).
• Excellent organisational skills with the ability to work under pressure and manage multiple priorities.
• Strong communication and interpersonal skills with the ability to work effectively cross-functional.
• Proactive, flexible, and comfortable operating within a rapidly evolving and growing business.

What We Offer

• A key role in a rapidly expanding, innovative medical device precision engineering environment.
• Opportunities for professional development and progression into senior engineering or specialist quality roles.
• A collaborative culture that values teamwork, technical excellence, accountability, and continuous improvement.
• The opportunity to make a meaningful impact on high-precision medical devices that improve patient outcomes worldwide.

Employment Type

Permanent or 12M FTC