QA Engineer: Medical Device Validation & Compliance

C&A Tool Engineering, Inc.; Auburn (IN); On-site; USD 28,000 - 40,000; Full time

Benefits offered by this job

Health insurance

Vision

Paid vacation

Company paid life insurance

Holidays

Tuition reimbursement

Job summary

C&A Tool Engineering, Inc. is seeking a qualified professional for a 100% on-site Validation/Quality role in Indiana. The candidate will lead IQ/OQ/PQ validation activities, develop validation plans, and support NPI and process optimization in a regulated manufacturing environment.

Required knowledge includes GD&T, metrology, GR&R, and regulatory compliance with ISO 13485 and FDA requirements, along with excellent communication skills and teamwork. On-site work and US citizenship are required.

Qualifications

• Bachelor’s degree in Engineering or related field with 3 years' experience.
• Knowledge of Quality and Medical Device regulations.
• Proficient with basic measuring instruments.
• Knowledge with GD&T and inspection methods.
• Knowledge with GR&R and capability studies.
• Excellent written and verbal communication skills.
• Strong knowledge of validation protocols and processes.
• On-site work required; US citizen at hire.

Responsibilities

• Lead IQ/OQ/PQ validation activities for equipment, processes and product introductions.
• Develop, review, and approve Validation Master Plans, protocols and reports.
• Support Design/Product Transfer, New Product Introduction (NPI) and process optimization projects.
• Maintain compliance with ISO 13485, FDA 21 CFR Part 820 and other applicable regulations/standards and internal quality system procedures.
• Drive root cause investigations and implement effective CAPA.
• Support internal audits, supplier audits and regulatory inspections as needed.
• Analyze quality data trends and recommend improvements to reduce defects and nonconformances.
• Ensure lot traceability, documentation accuracy and compliance with Device History Records (DHR).

Skills

GD&T

Metrology

Validation

GR&R

Inspection methods

Measuring instruments

Quality systems

Communication skills

On-site work

Regulatory knowledge

Education

Bachelor’s degree in Engineering

Associate degree in Technical Field with 3 years experience

Tools

Metrology equipment

Calibration instruments

Job description

C&A Tool Engineering, Inc. is seeking a qualified professional for a 100% on-site Validation/Quality role in Indiana. The candidate will lead IQ/OQ/PQ validation activities, develop validation plans, and support NPI and process optimization in a regulated manufacturing environment.

Required knowledge includes GD&T, metrology, GR&R, and regulatory compliance with ISO 13485 and FDA requirements, along with excellent communication skills and teamwork. On-site work and US citizenship are required.