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Jenn Smith is a Sr. Quality Production Engineer at Getinge. She possess expertise in leadership, test plans and summary reports, powerpoint, sap, root cause analysis and 18 more skills. Colleagues describe her as "First, I’d like to say that Jenn has a solid work ethic and a quality-first mindset. She has a proven track record for going above and beyond to provide leadership as a facilitator and project manager to her CAPA teams to ensure milestones are complete to meet strict KPIs and Metrics expectations set by the business. She also possesses the in-depth analytical skills necessary to solve complex software, hardware, and process problems, including the technical documentation skills to keep records compliant to industry regulations and standards. She is also a proactive communicator, can present data to across different businesses and levels of management, and escalate issues at appropriate intervals. Jenn would be an added value to any team as she can flex with change and anticipates when support is needed, and last but not least, a great human being!", "I’ve had the privilege of mentoring Jenn this year as part of a selective program at Philips - Jenn not only drives results in the mission critical area of Quality and Regulatory Compliance, she does so in an inclusive, mindful manner - showing that one can achieve substantial business results while being great to work with. A rare and valuable ability, particularly in the high stakes area of medical devices. She has also been a key supporter of mindfulness and mental health, leading sessions in Philips that have benefited numerous employees - a role model and strong part of any team she is part of", and "Jenn Smith is a passionate and engaged employee. Jenn cares. When there is something she is responsible or accountable for she owns it and ensures it is done properly. Jenn has shows the ability to grow both her breadth and depth of knowledge in her role as a CAPA Engineer. This allows her to lead by example to both her CAPA teams and peers. Jenn has shown willingness to step in and help others as well. She was a consistent soundboard for myself while we were peers. Above that, she has made herself available to assist with Work/Life balance -using her experience as a Yoga instructor to offer Mindfulness sessions across the company to help our employees be good people, not just good employees. Jenn is a strong writer and is able summarize complex situations into digestible packages. Jenn has presented month long CAPA Investigations to the Review Board in a matter of minutes - while also managing the Quality Records that are generated from the CAPA Review Board. Every year Jenn has gotten better and better at her role, taking feedback and evolving accordingly. Very excited to see where the rest of her career choices take her!"
Getinge
View- Website:
- getingegroup.com
- Employees:
- 8674
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Sr. Quality Production EngineerGetingeNashua, Nh, Us -
Senior Production Quality EngineerGetingeNashua, Nh, Us -
Sr. Quality Systems EngineerQuanterix Jun 2024 - PresentBillerica, Massachusetts, Us -
Full-Time ParentingCareer Break May 2023 - Jun 2024
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Yoga TeacherMountain Base Yoga Jul 2020 - May 2024 -
Senior Capa EngineerPhilips Jul 2017 - May 2023Amsterdam, Noord-Holland, NlQuality Management/Project Management:• Have facilitated over 50 CAPA’s and authored CAPA Projects from Investigation to Closure. • Managed approximately 10 CAPA Projects at any given time. • Consistently strove to meet target KPI of 90% of investigations completed within 90-days. • Coached project teams on CAPA Process and problem-solving tools such as Ishikawa, Fault Tree, 5-Why’s, Is/Is-Not, and Data Analysis to identify root cause(s). • Led CAPA Review Board as interim CRB Chair. Quality Audit:• Led backroom for Internal Audit April 2022.• Drove effective and timely resolution to all audit non-conformances including internal, Philips Group and external.• Supported internal and external audit preparation of documentation. • Supported Backroom for Internal, and BSI Audits. -
Quality Assurance EngineerT2 Biosystems Apr 2016 - Jun 2017Lexington, Ma, Us• Developed and implemented strategies to reduce complaint handling backlog from > 300 complaints to zero complaints within one year.• Generated standard operating processes on execution-of and maintenance-for Complaint Quality Trends. • Backroom Support for FDA Audit Inspection. -
Project Qa Specialist / Internal AuditorDeka Research & Development Dec 2015 - Apr 2016Manchester, Nh, Us• Decreased process waste by restructuring Maintenance Program: new SOPs and Quality History Records.• Performed internal audits in accordance with Company requirements, 21 CFR part 820, and ISO 13485. • Applied knowledge and experience to consistently refine QA processes to increase efficacy and reduce errors. -
Qa/ Biocompatibility Test EngineerDeka Research & Development Apr 2014 - Apr 2016Manchester, Nh, Us• Supported development of Sterilization Test Summary Report for Amia Automated PD System with Sharesource for 510k submission. • Specialized in Sterilization techniques (Ethylene Oxide and Gamma Radiation) for NPI projects. • Generated Test Plans, Reports, Verification & Validation Reports for sterilization – bioburden comparative resistance testing, sterility testing, particulate testing, and feasibility studies -
Qa Test TechnicianDeka Research & Development Nov 2013 - Apr 2014Manchester, Nh, Us•Executed test cases per test procedures accurately and in a timely manner. •Reported any anomalies noted while performing test cases. •Obtained knowledge on developmental software, and expanded upon scale abilities. -
Planning Production Control SpecialistRaytheon Integrated Defense Systems Jul 2013 - Sep 2013Arlington, Va, Us•Problem-solving abilities were enhanced in order to support the Inventory Control team. •Knowledge of SAP PRISM and MRP were enhanced, and Warehouse Management software was learned in order to investigate errors created by the system and people. -
Supply Chain SpecialistRaytheon Integrated Defense Systems Jul 2012 - Jul 2013Arlington, Va, Us• Investigated and initiated serialization of specific materials within system to determine if parts were appropriately labeled. The project was moved forward and eventually executed by senior management.• Interpersonal skills were combined with analytical abilities to support the Bill of Materials team.• Engineering change notices were analyzed, and alterations were made to Bill of Materials to reduce errors and streamline production.
Jenn Smith Skills
Jenn Smith Education Details
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Keene State CollegeGeneral
Frequently Asked Questions about Jenn Smith
What company does Jenn Smith work for?
Jenn Smith works for Getinge
What is Jenn Smith's role at the current company?
Jenn Smith's current role is Sr. Quality Production Engineer.
What is Jenn Smith's email address?
Jenn Smith's email address is je****@****ips.com
What schools did Jenn Smith attend?
Jenn Smith attended Keene State College.
What skills is Jenn Smith known for?
Jenn Smith has skills like Leadership, Test Plans And Summary Reports, Powerpoint, Sap, Root Cause Analysis, Complaint Management, Communication, Excel, Quality Assurance, Medical Devices, Microsoft Office, Warehouse Management.
Who are Jenn Smith's colleagues?
Jenn Smith's colleagues are Erdal Özgür, Mario Bassani, Anjum Belim, Fredrik Haarala, Prasada Reddy, Jim Fiordirosa, Ufuk Gürsoy.
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