29 Jul
R & D Engineer (CAPA) Medical Device
Vacancy expired!
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Who You Are:Someone who is passionate about performing investigations and solving complex problems. You are familiar operating within a quality system or regulated industry. You have experience with CAPAs, Non-conformances, Product Complaints and other types of quality records. The ideal candidate will have experience leading CAPAs and using various root cause analysis techniques, or the motivation to learn how to do so. You thrive in a fast-paced, multidisciplinary environment with significant growth and training opportunities.Flexible hours and a hybrid work-from-home schedule is available. However, this job will require some on-site work to conduct product or process investigations, engineering studies and testing, critical team meetings, training and other in-person events. Job Responsibilities And Essential Duties- Generates CAPA requests to escalate issues to CAPA Review Board (CRB) that require resolution through the CAPA system.
- Work’s cross-functionally to support CAPA requests generated from the CAPA feeder system related to high manufacturing scrap, product complaints and production non-conformances.
- Performs assessment of Product Complaints related to CAPA requests.
- Works with Quality Assurance to determine CAPA risk level and complete product containment activities as required.
- Leads CAPAs assigned to engineering groups, including creation and maintenance of CAPA documentation.
- Acts as project manager on assigned CAPAs by ensuring agreement of team actions, communication to key stakeholders and timely completion of all activities.
- Performs root cause analysis using appropriate tools and techniques, including Five Whys, Fishbone (Ishikawa) diagram, Is/Is-Not Analysis, etc.
- Performs corrective and preventive actions through the Change Control process.
- Implements design, process and quality system changes as needed to resolve CAPAs.
- Verifies accuracy and completeness of investigation and implementation actions performed by the CAPA team.
- Provides updates to CAPA Review Board (CRB) including leading CAPA Gate Reviews as required.
- Performs training on new or changing procedures as part of the implementation of solutions from CAPA.
- Works with Quality Assurance to ensure CAPAs are verified as effective and closed.
- Provides updates to the Senior Leadership Team (SLT) and Management Quality Review Board (MQRB) on status of assigned CAPAs as requested.
- Escalates issues related to resourcing, timelines or other issues encountered to upper management.
- Contributes to the team effort by accomplishing related tasks as needed.
- Bachelor’s degree in engineering, science, or another related field.
- A minimum of two years’ experience in the medical device industry (or other regulated industry) with relevant experience in root cause analysis and/or CAPA.
- Knowledge of 21 CFR Part 820.
- Strong experience with Microsoft Office applications (Word/Excel/PowerPoint) is required.
- Demonstrated ability to solve technical challenges with cross-functional teams.
- Strong analytical and problem-solving skills.
- Strong communication and collaboration skills.
- Self-motivated with the ability to accomplish project goals with minimal supervision.
- Experience with Agile PLM and Track Wise is highly desired.
- Knowledge of Good Documentation Practices (GDP) required.
- Excellent verbal and written communication skills.
- None
- CAPA
- Investigation
- Route Cause Analysis (RCA)
- Change control
Vacancy expired!