Quality Assurance Engineer

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 Quality Engineer is accountable for ensuring that new or modified products are developed and released meeting customer expectations, regulatory requirements, appropriate standards, and Kestra policies and procedures. 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 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 Quality Engineer is accountable for oversight of system quality, post‑market surveillance analytics, reporting, and risk management throughout the product life cycle.

• 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.
• 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.
• Provide statistical support and analytical expertise for product development.
• Represent QA in product Risk Analysis updates, 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.
• Support Notified Body/Regulatory Agency/Customer engagements.
• Perform other related duties as assigned.

• Passion:
  Contagious excitement about the company – sense of Commitment to continuous improvement.
• Integrity:
  Commitment, accountability, and dedication to the highest ethical standards.
• Collaboration/Teamwork:
  Inclusion of Team Member regardless of geography, position, and product.
• Action/Results:
  High energy, decisive planning, timely execution.
• Innovation:
  Generation of new ideas from original concepts.
• Customer Focus:
  Exceed customer expectations, quality of products, services, and experience always present of mind.
• Emotional Intelligence:
  Recognizes, understands, manages one’s own emotions, and is able to influence others, a critical skill for pressure situations.

Education/Experience

Required:

• Bachelor’s Degree in Engineering, Science, or technical field with 2+ years of work experience in Engineering and/or Quality.
• Significant experience in risk management throughout the product lifecycle, including 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.

• Experience in Design controls for Electromechanical Devices and Disposables, including Risk Management, Design Verification, Design Validation, Test Method Validation.
• Knowled…