The R&D Engineer, CAPA will be part of an exciting new team within R&D working directly with Product Sustaining Engineering and Manufacturing Engineering on all CAPA-related activities. Responsibilities include leading investigations and creating implementation plans that enhance our quality system and improve the quality of our products. This position supports our commercially released class I, II, and III medical devices, which includes chest drainage devices, vascular grafts and balloon expandable covered stents.
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.
This position is responsible for all CAPA activity for the engineering departments. Duties include supporting CAPA requests, performing complaint reviews, developing CAPA quality plans, performing root cause analysis and implementing corrective and preventive actions. This role woks collaboratively across the organization to investigate and resolve both quality system and product quality issues.
Job Responsibilities and Essential Duties
- Generates CAPA requests to escalate issues to CAPA Review Board (CRB) that require resolution through the CAPA system.
- Works 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 other 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.
Required Knowledge, Skills and Abilities
- 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 TrackWise is highly desired.
- Knowledge of Good Documentation Practices (GDP) required.
- Excellent verbal and written communication skills.
Supervision/Management of Others
Internal and External Contacts / Relationships
- Main contacts, internal;
- Product Sustaining Engineering group members
- R&D Staff including New Product Development and Research Groups
- Executive Management Staff
- Operations Management and Staff
- Supply Chain Management and Staff
- Marketing Management and Staff
- QA/RA Management and Staff
- Finance Management and Staff
- Sales Management and Staff
- Main contacts, external;
- Key Opinion Leaders / SMEs
- Third-Party Contractors and Service-Providers
- Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
- Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (as applicable to the job function).
- Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (as applicable to your job function).
- Attend all required Quality & Compliance training at the specified interval.
- Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.
Environmental/Safety/Physical Work Conditions
- Ensures environmental consciousness and safe practices are exhibited in decisions.
- May work extended hours during peak business cycles.
- This position may require some travel to Getinge or partner sites (<5%).
The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Each organization shall establish the appropriate authority, and interrelation of all employees who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.
The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.
We look forward to receiving your application. If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application. We hope you will join us on our journey to become the world's most desired medtech company.
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