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