MicroVention-Terumo · 2 months ago
Sr. Quality Systems Engineer
Aliso Viejo, California, USA
Full-time
Onsite
Mid, Senior Level
$100K/yr - $133K/yr
3+ years expMicroVention-Terumo is a leader in the medical device industry, and they are seeking a Senior Quality Systems Engineer to maintain and improve quality systems in compliance with global regulatory requirements. The role involves supporting CAPA processes, conducting audits, and driving quality improvement initiatives within the organization.
Health CareManufacturingMedicalNeuroscience
Responsibilities
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
Qualification
Required
Bachelor's Degree required or equivalent experience
A minimum of three (3) to five (5) years of quality assurance/compliance related experience in the medical device industry
Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations and Application of Good Manufacturing Practices
Demonstrates understanding of and adherence to Good Documentation Practices
Demonstrates use of investigation techniques, root cause investigation tools, determining appropriate and effective corrective actions, and how to thoroughly document CAPAs
Strong interpersonal skills, team player with good problem-solving ability, and good verbal and written communication skills
Strong analytical and attention to detail skills
Successful experience working independently and collaboratively, effectively and confidently in a team environment
Ability to communicate effectively and partner with associates at various levels within the organization
Proficient with MS Word, Excel, PowerPoint, Visio and Outlook
Preferred
Lean Six Sigma, Quality, and/or Project Management related certification, preferred
Knowledgeable in 21CFR Part 820, ISO13485, ISO14971, EMDR/MDD, MDSAP and CMDCAS regulations
Company
MicroVention-Terumo
MicroVention is now Terumo Neuro.
1001-5000 employees
H1B Sponsorship
MicroVention-Terumo has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (15)
2023 (7)
2022 (14)
2021 (8)
2020 (9)
Funding
Current Stage
Late StageTotal Funding
$51.6MKey Investors
Crosspoint Venture PartnersU.S. Venture PartnersAdvanced Technology Ventures
2006-02-28Acquired
2003-09-04Series D· $10M
2002-08-30Series D· $19M
Leadership Team
A
Amy L. Walters
Vice President, Global Clinical Research
Rob Greene
Senior VP, R&D
Recent News
Google Patent
2025-05-06
Google Patent
2025-05-06
Company data provided by crunchbase