Quality Assurance Engineer
About The Position
The 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. 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.
Requirements
- 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
- Proficient in Microsoft Office
- Excellent communication skills and proven ability to work as part of a
- Able to handle multiple tasks/projects and manage priorities
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
- 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
- Experience driving risk management discussions, particularly as it relates to cascading identified product issues/hazards into potential user harms.
- American Society of Quality (ASQ) certification (CQE, CQA, CQM, )
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
- 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
- Represent QA in product Risk Analysis updates for assigned 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
- Perform other related duties, as assigned
Benefits
- Medical
- Dental
- 401K with Match
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
