Principal Engineer Quality

Olympus Corporation of the Americas

False Pass (AK)

Remote

USD 140,000 - 200,000

Full time

14 days+

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Benefits offered by this job

Competitive salary

Medical, dental, vision coverage

401(k) with company match

Paid time off and parental leave

Job summary

Olympus Corporation of the Americas seeks a Principal Quality Engineer to lead product quality across the lifecycle from design through post-market. You will partner with R&D, Manufacturing, Regulatory, and Post-Market teams to identify, assess, and resolve quality issues while ensuring regulatory compliance.

Role requires 10+ years in medical device quality, CAPA leadership, strong data analytics, and the ability to travel regionally/internationally.

Qualifications

Bachelor's degree in Engineering or related field required.
10+ years of product quality experience in medical devices or regulated environments.
Experience with design transfer, process validation, CAPA systems, and investigations.
Experience leading cross-functional problem-solving teams.
Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
Excellent analytical, communication, and leadership skills.

Responsibilities

Lead end-to-end product quality across the lifecycle.
Act as escalation point for quality issues, metrics and risk management.
Provide QA leadership for AIRs, Health Hazard Assessments, and escalations.
Ensure compliance with 21 CFR Part 820, ISO 13485, and global regulations.
Drive CAPA effectiveness, root-cause analysis, and MRB support.
Improve quality systems and process controls through data-driven methods.

Skills

Product quality leadership

Regulatory compliance

CAPA leadership

Risk management

Cross-functional collaboration

Data analysis

Education

Bachelor's degree in Engineering

Tools

CAPA systems

Process validation

Statistical analysis

Job description

Working Location: Massachusetts, Westborough; Nationwide

Workplace Flexibility: Remote

_For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling. _ __

Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

Our five Core Values empower us to achieve Our Purpose:

Patient Focus, Integrity, Innovation, Impact and Empathy.

Learn more about Life at Olympus: https://www.olympusamerica.com/careers .

Job Description

The Principal Quality Engineer is the primary point of contact for all product quality matters across the product lifecycle. This role provides end-to-end product quality leadership, ensuring compliance with regulatory requirements and internal standards while driving continuous improvement. The individual partners cross-functionally with R&D, Manufacturing, Regulatory, Supply Chain, and Post-Market teams to proactively identify, assess, and resolve product quality issues.

Job Duties

Product Quality Leadership

Serve as the division's key partner and subject matter expert for end-to-end product quality.
Act as the primary escalation point for product quality issues, metrics, and risk management activities.
Provide Product QA leadership for all AIRs (Adverse Incident Reports), HHA/FCAs (Health Hazard Assessments/Field Corrective Actions), and product escalations, determining potential cross-product or systemic impact.
Ensure alignment with regulatory requirements including 21 CFR Part 820, ISO 13485, and applicable global regulations.

Corrective and Preventive Action (CAPA)

Determine and implement robust corrective and preventive actions to address product and process deficiencies.
Lead structured, formal problem-solving teams (e.g., 8D, DMAIC, root cause analysis) to resolve significant customer, product, and supplier complaints.
Oversee CAPA effectiveness checks and ensure sustainable systemic improvements.

Nonconformance & MRB Support

Support and provide leadership to the Materials Review Board (MRB) in investigation and disposition of nonconforming materials (NCRs).
Drive timely resolution of product quality issues through cross-functional collaboration.

Risk Management & Process Controls

Facilitate and support cross-functional execution of:
- Process Flowcharts
- PFMEAs
- Control Plans
- Procedures and Work Instructions
- Inspection Data Sheets
Lead implementation and continuous improvement of quality systems, assurances, and process controls designed to meet or exceed internal and external requirements.
Utilize strong data analysis and trending skills to identify emerging risks, assess failure modes, and recommend mitigation strategies.

Job Qualifications

Required:

Bachelor's degree in Engineering or related technical field required.
10+ years of product quality experience in the medical device industry or other regulated environment.
Demonstrated experience with design transfer, process validation, CAPA systems, and complaint investigations.
Experience leading cross-functional problem-solving teams.
Strong working knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and risk management principles (ISO 14971).
Strong analytical and statistical data analysis capabilities.
Excellent root cause investigation and structured problem-solving skills.
Proven leadership and cross-functional collaboration abilities.
Strong written and verbal communication skills.
Ability to influence without direct authority and manage multiple priorities in a dynamic environment.
Must be available for regional and international travel.

Preferred:

Advanced degree preferred.

Why join Olympus?

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

Equitable Offerings you can count on: