Sr. Engineer, Quality Systems

Terumo Neuro; California (MO); On-site; USD 120,000 - 170,000; Full time

Job summary

Terumo Neuro is seeking a Sr. Engineer, Quality Systems to actively maintain and improve quality systems in support of global regulatory requirements.

The role analyzes metrics, updates procedures, and drives CAPA/QAR/audit-related activities with cross-functional partners to ensure on-time delivery of corrective actions. The ideal candidate has 3–5 years in medical device quality/compliance, hands-on CAPA leadership, and strong knowledge of FDA regulations, GMP, and GMP-based documentation

Qualifications

• Bachelor's Degree in a related field. 3–5 years of quality assurance/compliance experience in medical devices preferred.
• Experience with FDA regulations, GMP, and Good Documentation Practices.
• Proven root cause investigation techniques and CAPA management.
• Strong written and verbal communication, and cross-functional collaboration.
• Ability to manage multiple projects and maintain CAPA records and audit readiness.
• Experience supporting internal and external audits (FDA/notified bodies).
• Proficient with MS Word/Excel/PowerPoint/Visio.

Responsibilities

• Maintain and improve quality systems to ensure regulatory compliance.
• Lead CAPA investigations and drive on-time closure with cross-functional teams.
• Prepare data and host CAPA Review Board meetings, audits, and inspection support.
• Develop and analyze quality system metrics and trends for process improvement.
• Create and revise procedures to ensure compliance and continuous improvement.
• Cross-train as internal auditor to support internal audit processes.

Skills

CAPA

FDA Regulations

Good Documentation Practices

Root Cause Analysis

Quality Systems

Internal Audits

Quality Metrics

Regulatory Compliance

GMP

Cross-functional Collaboration

Microsoft Office

Education

Bachelor's Degree

Tools

MS Word

Excel

PowerPoint

Visio

Outlook

Job description

13858BR

Title

Sr. Engineer, Quality Systems

Job Description

This is a hands-on position in which the Senior Quality Systems Engineer is an active contributor to maintaining and improving quality systems to ensure compliance with global regulatory requirements and ensuring that the quality systems are used effectively to support company quality policy and objectives. Supports the preliminary investigation on CAPA/QAR/audit findings, prepares and analyzes reports/metrics, updates procedures and participates/facilitates Quality Systems related discussion. Drives activities related to Quality System improvements. Job duties:

• Maintains CAPA process.
• Partners with the CAPA owners to investigate issues related to audit findings, CAPA and QAR by collaborating with various functions (e.g., R&D, Production, Field Assurance, etc.).
• Facilitates CAPA Review Board meetings, prepares data to be analyzed for CAPAs, and follows up on actions to drive on-time delivery of committed actions.
• Leads and supports CAPA owners in understanding and conveying problem statements, conducting thorough root cause investigations and analysis, proposing logical and achievable corrective/preventive actions, and following up to ensure actions are completed on time and effective.
• Maintains CAPA records to ensure that they are presentable.
• Supports auditing activities and provides leadership for internal audits conducted by MicroVention associates or consultants.
• Supports preparation and hosting activities for third party audits including FDA, Notified Body, corporate and international regulatory authorities' audits. Supports follow-up efforts.
• Prepares and improves quality system metrics, and regularly analyzes trends to drive improvement on overall Quality System program.
• Partners with associates in other functions to evaluate and analyze the efforts in organizing, documenting and making recommendations to management on quality improvement process.
• Develops and conducts quality related training, including CAPA process, conducting root cause investigations, and quality improvement processes.
• Leads the planning and implementation of quality improvement initiatives.
• Identifies and escalates critical issues that warrant further actions.
• Creates and/or revises procedures to ensure compliance or drive improvement.
• Cross-trained as internal auditor to support Internal Audit process.
• Performs additional responsibilities as assigned.

Auto req ID: 13858BR

Location MV: Aliso Viejo, California, USA

Department Name: 526-Quality Systems

Qualifications

1. Bachelor\'s Degree required or equivalent experience.
2. A minimum of three (3) to five (5) years of quality assurance/compliance related experience in the medical device industry.
3. Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations and Application of Good Manufacturing Practices.
4. Demonstrates understanding of and adherence to Good Documentation Practices.
5. Demonstrates use of investigation techniques, root cause investigation tools, determining appropriate and effective corrective actions, and how to thoroughly document CAPAs.
6. Strong interpersonal skills, team player with good problem-solving ability, and good verbal and written communication skills.
7. Strong analytical and attention to detail skills.
8. Successful experience working independently and collaboratively, effectively and confidently in a team environment.
9. Ability to communicate effectively and partner with associates at various levels within the organization.
10. Proficient with MS Word, Excel, PowerPoint, Visio and Outlook.

Desired Qualifications

1. Lean Six Sigma, Quality, and/or Project Management related certification, preferred.
2. Knowledgeable in 21CFR Part 820, ISO13485, ISO14971, EMDR/MDD, MDSAP and CMDCAS regulations.

EEO

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, veteran status, marital status or any other characteristics protected by law.

Fair Chance Ordinance

If you are applying to perform work for Terumo Neuro in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Terumo Neuro reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

Terumo Neuro will consider for employment qualified job applicants with arrest or conviction records in accordance with the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair Chance Initiative for Hiring Ordinance