What are the responsibilities and job description for the Quality Engineer position at ENNOVI?
Quality Engineer
About Company
At ENNOVI we harness the power of two megatrends - electrification and AI - to help industries innovate at speed, operate smarter, and achieve sustainable growth. By combining these transformative forces with our global reach and best talent, we empower our customers to lead their markets and drive sustainable progress.
From automotive to aerospace, consumer electronics, data storage, industrial, and medical markets, we help our customers achieve these megatrends by creating smarter, safer, and more sustainable solutions.
We excel in developing high-performance, custom solutions that meet diverse technical needs, solve unique challenges, optimize performance, and adapt to evolving market demands.
Our mission is to get customers to the future faster, from anywhere. Headquartered in Singapore, ENNOVI has a global presence across North America, Europe, SEA and China, where all its activities are socially responsible, with minimal environmental impact. Learn more at www.ennovi.com.
Why Join Us
At ENNOVI, we envision a future of electrification and innovation and strive to create an inspiring workplace where our employees are integral to shaping that future. We offer a dynamic, collaborative, and inclusive culture that encourages continuous learning, professional growth, and a sense of purpose. As a part of the ENNOVI team, employees experience the excitement of being at the forefront of cutting-edge technologies and contributing to a sustainable future.
Our commitment to the transformation is epitomized by our five pillars: Speed, Innovation, Best Talent, Global Reach, and Sustainability. This entails navigating exponential market changes through agile structures, fostering innovation across all aspects of our business, strategically expanding our global footprint, championing sustainability initiatives and nurturing a winning team.
Privacy Policy
ENNOVI is an equal opportunity employer in conformance with all applicable laws and regulations to individuals who are qualified to perform job requirements. The Company administers its personnel policies, programs, and practices in a non-discriminatory manner in all aspects of the employment relationship, including recruitment, hiring, work assignment, promotion, transfer, termination, wage and salary administration, and selection for training.
By applying to this job posting, you agree with and acknowledge our privacy policy.
About the Medical Business
ENNOVI Medical is the medical-focused division within ENNOVI, created as part of the company’s strategic expansion “Beyond Automotive,” which brought Interplex Medical under the ENNOVI brand. The division delivers precision, scalable, and highly reliable medical solutions that enable OEMs to develop mission‑critical smart medical devices. These solutions support applications such as diagnostics, continuous glucose monitoring (CGM), and minimally invasive surgical technologies.
Core Capabilities
ENNOVI Medical leverages ENNOVI’s deep expertise in mechanical and electrical interconnect systems to provide customized components and assemblies specifically engineered for medical applications. These capabilities support high‑performance devices requiring robust connectivity, miniaturization, and precision manufacturing.
Position Summary
The Quality Engineer will be responsible for ensuring products meet regulatory standards and supports design, development and compliance. This position supports the development and implementation of the quality system including preventive and corrective actions, non-conformance control, and continuous improvement and quality system effectiveness. Provides a single point of contact for assigned projects.
This position is located in Tamarac, Florida
Main Responsibilities
- Develop, implement, and maintain Quality Management System (QMS) processes and procedures to ensure compliance with applicable regulatory, customer, and internal requirements (e.g., ISO 13485, FDA QSR).
- Serve as a quality representative for New Product Initiatives (NPI), supporting design transfer, process development, and product launch activities from a quality and regulatory perspective.
- Participate in NPI activities including design reviews, risk management (DFMEA/PFMEA), control plan development, inspection strategy definition, and validation planning to ensure robust, compliant product realization.
- Support process and product validation activities (IQ/OQ/PQ), including review and approval of protocols and reports for manufacturing processes such as machining, cleaning, passivation, and cleanroom operations.
- Analyze quality data (nonconformances, complaints, scrap, rework, yield, trends) to identify systemic issues, perform root cause analysis, and lead or support corrective and preventive actions (CAPA).
- Collaborate cross‑functionally with Manufacturing, Engineering, R&D, Supply Chain, and Operations to resolve quality issues, implement process improvements, and reduce variation and defects.
- Review and approve quality‑related documentation including procedures, work instructions, product specifications, drawings, inspection plans, change controls, and deviations.
- Support internal, customer, and regulatory audits by preparing documentation, participating in audits, responding to findings, and ensuring timely and effective closure of actions.
- Work with suppliers to support supplier qualification, incoming inspection strategies, supplier corrective actions, and ongoing supplier quality performance monitoring.
- Drive continuous improvement initiatives using structured problem‑solving and quality tools (e.g., Lean, Six Sigma, SPC), with a focus on product quality, process capability, and compliance.
- Ensure manufacturing and quality activities are executed in accordance with cleanroom requirements and controlled environment standards, as applicable.
Qualifications
- Bachelor’s degree in Engineering, Quality, or a related technical discipline.
- 3–5 years of experience in a Quality Engineering or related role within a regulated manufacturing environment; medical device experience strongly preferred.
- Working knowledge of quality systems and regulatory standards such as ISO 13485, ISO 9001, FDA QSR, and applicable GMP requirements.
- Experience supporting NPI / NPD activities, including design transfer, validation, risk management, and launch readiness.
- Proficiency with quality tools and methodologies including CAPA, root cause analysis (5 Whys, Fishbone), FMEA, SPC, and basic statistical analysis.
- Ability to read and interpret technical drawings, specifications, and manufacturing documentation.
- Experience supporting machining, cleaning, passivation, or cleanroom manufacturing processes is a plus.
- Strong analytical, organizational, and problem‑solving skills with attention to detail.
- Effective written and verbal communication skills, with the ability to work collaboratively across functions and present quality information clearly.
- Experience supporting audits and interfacing with customers or regulatory bodies preferred.