Senior Quality Engineer
About The Position
The Kestra team has over 400 years of experience in the external and internal cardiac medical device markets. The company was founded in 2014 by industry leaders inspired by the opportunity to unite modern wearable technologies with proven device therapies. Kestra’s solutions combine high quality and technical performance with a wearable design that provides the greatest regard for patient comfort and dignity. Innovating versatile new ways to deliver care, Kestra is helping patients and their care teams harmoniously monitor, manage, and protect life. The Senior Quality Engineer is accountable for assuring new or modified products are developed and released meeting customer expectations, regulatory requirements, appropriate standards, and Kestra policies and procedures. This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, and system/services support. The role actively participates in product development and transfer activities, ensuring product and process conformance to FDA QSR, ISO 13485, and EU MDR requirements. The Senior Quality Engineer is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. In addition, the Senior Quality Engineer is accountable for oversight of system quality, post-market surveillance analytics, reporting, and risk management throughout the product life cycle.
Requirements
- Bachelor’s Degree in Engineering, Science, or technical field with 5+ years of work experience in Engineering and/or Quality.
- Minimum 3 years of proven ability with FDA regulated industry, preferably on product development programs.
- Significant experience in risk management throughout the product lifecycle, including strong working knowledge of 21 CFR 820.30, ISO 14971, EU MDR, IEC 62304, and cybersecurity.
- Demonstrated ability to utilize agile methodologies to arrive at difficult engineering decisions quickly.
- Excellent communication skills and proven ability to work as part of a team.
- Able to handle multiple tasks/projects and manage priorities accordingly.
Nice To Haves
- Experience in Design controls for Electromechanical Devices and Disposables, including Risk Management, Design Verification, Design Validation, Test Method Validation.
- Knowledge of manufacturing processes.
- Understands applied statistics concepts for Quality and Reliability, statistical sampling plans, statistical process control, and advanced statistical methodologies such as DOE.
- Working knowledge of quality techniques such as root cause analysis, 5 why's, and Ishikawa diagrams.
- Experience driving risk management discussions, particularly as it relates to cascading identified product issues/hazards into potential user harms.
- Experience supporting ISO 13485 inspections and FDA inspections.
- American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) and Lead Auditor certification.
- Proficient in Microsoft Office programs.
Responsibilities
- Support ongoing Quality activities including, but are not limited to, acting as real-time support to outsourced manufacturing, protocol/report creation, product testing support, document review /development, root cause identification/support, Risk Management activities, CAPAs & support.
- Champion continuous improvement through CAPA system, handling of complaints, analyzing key performance indicators, etc.
- Act as the QA representative on Design Projects supporting new product introductions, qualification of new suppliers, development, and approval of new product documentation in support of electromechanical systems that utilize microcontroller technology, customized/off the shelf PCBs, and software applications.
- Participate in project design reviews to ensure that designs adhere to guidelines and standards.
- Prioritize timely completion of complaint investigations, Corrective Action and Preventive Action (CAPA) decisions, and Device History Record (DHR) reviews, ensuring that corrective action decisions and investigations are based on sound engineering analysis and review.
- Provide statistical support and expertise and analytical problem solving for product development and manufacturing.
- Maintain, monitor, and report trend analysis information. Initiate discussions with management via the product quality meetings or other appropriate forums.When new failure mode trends are identified, provide field performance data as it becomes available.
- Represent QA in product Risk Analysis updates for assigned products. Maintain product risk management file for a commercial product, including design and process failure mode effects analysis (dFMEA, pFMEA), post-market surveillance report (PMSR), risk management plan, and report (RMP, RMR).
- Represent Kestra RA/QA as part of the Material Review Board at contract manufacturers
- Participate in Internal and Supplier Audits.
- Support Notified Body / Regulatory Agency / Customer Audits.
- Prepare responses for regulatory inquiries (FDA, OUS regulators) as assigned.
- Perform other related duties, as assigned
Benefits
- Kestra offers a very competitive benefit package including Medical, Dental, 401K with Match, etc.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
