Quality Engineer- Medical Device development
Phillips-Medisize, a Molex company, is looking for an experienced Quality engineer for Global Innovation Development in Bangalore, India. If you are interested in being part of a project organization and passionate about creating unique products for people who need medical treatment it might be you, we are looking for.
Your Job
The Quality Engineer (QE) will play a critical role in ensuring compliance with regulatory requirements and internal quality standards throughout the product development lifecycle. This position will primarily support Design History File (DHF) documentation and act as a Quality Assurance partner for cross-functional teams involved in medical device design and development.
What You Will Do In Your Role
For our new Quality engineer the field of work will be Quality Assurance in Medical Device development division and you will do below activities-
- Ensure completeness, accuracy, and compliance of DHF documentation per FDA 21 CFR Part 820, ISO 13485, and other applicable standards.
- Review and approve design documentation including design inputs, outputs, risk management files, verification & validation protocols/reports, and design transfer records.
- Maintain DHF with all running changes and updates.
- Provide QA oversight during product development phases, ensuring adherence to design control procedures.
- Participate in design reviews, risk assessments, and change control processes.
- Support internal and external audits related to design controls and DHF.
- Maintain awareness of global regulatory requirements for medical devices and ensure design documentation aligns with these standards.
- Support preparation of technical documentation for regulatory submissions.
- Identify gaps and propose improvements in design control processes and documentation practices.
- Train and mentor team members on quality and regulatory requirements related to design controls.
- Ensure risk management activities comply with ISO 14971 and are integrated throughout the design process.
- Review and approve engineering change orders (ECOs) for design-related changes.
- Collaborate with R&D to ensure design verification and validation activities meet regulatory and internal requirements.
- Support CAPA investigations related to design issues and ensure timely closure.
- Maintain and improve QMS processes related to design control, document control, and records management.
- Ensure compliance with ISO 13485 requirements for design and development processes.
- Participate in supplier qualification and evaluation for design-related components.
- Support management reviews by providing quality metrics and DHF compliance status.
- Assist in preparation and maintenance of SOPs related to design control and QMS.
- Monitor and report on key quality indicators for design and development activities.
- Drive continuous improvement initiatives within design quality and QMS processes.
The Experience You Will Bring
Requirements:
- Minimum Bachelor’s degree/Diploma in engineering.
- Minimum 7+years of experience working as a Quality Engineer for medical device industry and any other regulated environment.
- High understanding of the importance of maintaining a high level of quality and documentation.
- Result oriented and a self-motivated team player.
- Pro-active in identifying and implementing potential improvement and proposing Lean solutions.
- Knowledge of ISO 13485, 21 CFR part 820
- Experience on complete medical device product development cycle
- Fluent in English, both spoken and written.
What Will Put You Ahead:
- Knowledge of investigation tools
- Proficiency with MS Office, MS Excel, MS Power Point
We offer you
- A great work culture which is highly human centric driven under the guidance of Principle based management which foster everyone to learn & grow to achieve career aspirations.
- A challenging position in an international innovative and successful company that is growing.
- An opportunity to setup the processes and development team in India to support the Indian customers.
- An opportunity to become part of a global team of dedicated and highly qualified colleagues based in Bangalore, India.
- Well-structured training and continuous development of your competencies.
- Exciting career possibilities within the constantly growing area of medical devices.
- Salary on a competitive level.
The Company – In Short
Phillips Medisize is an expert in the design, development and delivery of advanced drug delivery devices and connected health solutions. Our customers are leading pharmaceutical companies worldwide. We offer innovative and integrated solutions supported by an end-to-end service offering from Strategy to Launch. Phillips Medisize is a part of Molex. We have opened a new Global Innovation and Development center in Bangalore, India and expected to grow in the Asian region.
At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.
Who We Are
At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.
