Quality Engineer

Applied Medical; Rancho Santa Margarita (CA); On-site; USD 71,000 - 75,000; Full time

Benefits offered by this job

Competitive compensation package

Education reimbursement

401(k) with employer match

Vacation accrual and paid holidays

On-campus wellness activities

Mentorship and training

Job summary

Applied Medical is seeking a Quality Engineer to support product quality, regulatory compliance, and manufacturing excellence in a regulated medical device environment.

You will develop and maintain quality systems, review documentation, and assist with CAPA and audits while collaborating with design and manufacturing teams to ensure risk is managed and processes meet customer and regulatory requirements.

Qualifications

• Bachelor's degree in engineering, physical sciences, biological sciences, or another technical discipline.
• Strong technical writing skills for SOPs, test methods, and quality documentation.
• Analytical, meticulous, and detail-oriented approach to quality and processes.
• Ability to work independently and collaboratively within a cross-functional team.
• Strong organizational skills with multitasking and prioritization.
• Effective oral and written communication and presentation skills.
• Proficiency in English (reading, writing, and speaking).
• Preferred: Quality systems training (QSR/GMP, ISO).
• Minimum: 1 year in medical device industry.

Responsibilities

• Review and approve DMR documents, IQ/OQ/PQ protocols and reports.
• Create/validate test methods for design verification and manufacturing inspection testing.
• Document and review Non-Conformance Investigations (NCIR).
• Coordinate clean room maintenance and improvement projects.
• Develop and maintain Environmental Monitoring Plans and Reports; perform investigations and root-cause analyses.
• Support CAPA, internal and external audits.
• Investigate root causes for quality/manufacturing issues; implement corrective actions.
• Create/update SOPs and Job Aids.
• Collaborate with design/manufacturing to assess device risk and pfMEA.
• Conduct experiments, apply statistics to sample sizes and confidence levels.
• Assist with training new team members.

Skills

Technical writing

Analytical thinking

Independent work

Cross-functional collaboration

Communication

English proficiency

Education

Bachelor's degree in engineering/technical field

1 year in medical device industry (preferred)

Tools

Gage R&R

Measurement systems analysis

Job description

Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions.

Position Description

The Quality Engineer supports product quality, regulatory compliance, and manufacturing excellence at Applied Medical by working within a cross-functional team to develop, maintain, and improve quality systems and documentation. This role is well-suited for candidates with a background in quality engineering, process engineering, or medical device quality assurance who are looking to apply their technical skills in a regulated manufacturing environment. The Quality Engineer contributes directly to process validation, risk management, and documentation integrity across the product lifecycle.

Key Responsibilities

• Review and approve Device Master Record (DMR) documents, as well as protocols and reports for Installation, Operational, and Performance Qualification (IQ, OQ, PQ)
• Create and validate test methods for design verification and manufacturing inspection testing by utilizing techniques such as measurement system analysis and Gage Repeatability & Reproducibility (Gage R&R)
• Document and review Non-Conformance Investigations (NCIR)
• Propose, investigate, and coordinate clean room maintenance and improvement projects
• Develop and maintain Environmental Monitoring Plans and Reports for top‑level manufacturing areas, performing investigations and root cause analyses for any abnormalities in environmental data trends.
• Support Corrective and Preventative Actions (CAPA), Internal and External Audit
• Investigate root causes for quality and manufacturing issues, document results and implement corrective actions
• Create and update Standard Operating Procedures (SOPs) and Job Aids
• Collaborate with design and manufacturing teams to assess device risk profile, identify failure modes in manufacturing (pFMEA)
• Conduct experiments to prove hypotheses and implement statistical techniques to determine appropriate sample sizes and levels of confidence
• Assist with training of new team members

Success in This Role Looks Like

• Collaborating effectively across engineering, manufacturing, and quality teams to support process improvement and compliance.
• Demonstrating a proactive, detail‑oriented approach to identifying and resolving quality and process challenges.
• Supporting a culture of quality and continuous improvement within the manufacturing environment.
• Contributing to audit readiness through organized, complete, and traceable documentation practices.

Position Requirements

This Position Requires the Following Skills and Attributes

• Bachelor's degree in engineering, physical sciences, biological sciences, or another technical discipline; or equivalent experience.
• Strong technical writing skills with the ability to create and maintain SOPs, test methods, and quality documentation.
• Analytical, meticulous, and detail‑oriented approach to quality and process‑related work.
• Ability to work independently and collaboratively within a cross‑functional team environment.
• Strong organizational skills with the ability to multitask and prioritize effectively.
• Effective oral and written communication and presentation skills.
• Ability to read, write, and speak English and comprehend work and safety instructions.

Preferred

The Following Skills and Attributes Are Preferred

• Training in quality systems including Quality System Regulation and Good Manufacturing Practices (QSR/GMP) and relevant International Organization for Standardization (ISO) standards.
• Understanding of quality principles within a regulated manufacturing or medical device environment.
• Minimum of one year of experience in the medical device industry.

Benefits

• Competitive compensation range: $71,000 - $75,000 / year (California).
• Comprehensive benefits package.
• Training and mentorship opportunities.
• On-campus wellness activities.
• Education reimbursement program.
• 401(k) program with discretionary employer match.
• Generous vacation accrual and paid holiday schedule.

Please note that the compensation range may be adjusted in the future, and bonus and incentive compensation plans may apply.

Our total reward package reflects our commitment to employee growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life.

All compensation and benefits are subject to plan documents and written agreements.

Equal Opportunity Employer

Applied Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other status protected by federal, state or local laws in the locations where Applied Medical operates.