Job
Description
Join a high-performing group with a purpose: to grow a safer, cleaner, healthier future for everyone, every day. We are hiring for Design Quality Engineer in Halma company MST Location - Bengaluru Business Unit - Healthcare Report to - Sr. Quality Systems Manager We are simple, humble and approachable , and we believe in leadership at all levels to bring our purpose to life. Everyone at Halma India makes an impact, and so do you when you join us! About us Halma is a global group of life-saving technologies companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US Our diverse group of nearly 50 global companies specialise in market leading technologies that push the boundaries of science and technology. For over 50 years, the combination of our purpose, strategy, people, DNA and sustainable business model has resulted in record long-term growth in revenues and profits and an increase in dividend by ≥ 5% every year – an achievement unrivalled by any company listed on the London Stock Exchange. We have a team of over 250 professionals representing commercial, digital and support functions across our seven offices in India, two in Bengaluru and one each in Delhi, Mumbai, Thanjavur, Vadodara, and Ahmedabad. HALMA INDIA IS CERTIFIED AS A GREAT PLACE TO WORK. Here’s why working with us is fulfilling: We offer a safe and respectful workplace , where everyone can be who they ‘REALLY’ are, feel free to bring their whole selves to work and use their unique talents, knowledge, expertise, experiences, & backgrounds to create meaningful outcomes. We nurture entrepreneurial spirits and empower them to think beyond the possibilities, to discover, shape and build their own unique stories. Our diverse businesses and operations provide fulfilling opportunities to grow as individuals and make an impact. Detailed job description About Halma company MST MST's passion is creating exceptional surgical devices and instruments used to restore or improve sight for patients all over the world. It is our relentless pursuit of addressing our customers’ needs that creates a profound customer preference. We strive to equip surgeons with the most innovative tools, enabling them to achieve the best possible outcomes for the patients. We constantly evolve to meet the distinct clinical needs of ophthalmic surgeons through our dedicated partnership with surgeon-designers, bringing innovation to ophthalmology. Expanding our offerings into excisional goniotomy, we now market micro-instruments used for adult and infantile glaucoma, which improve the health and livelihood of patients by providing a safe and effective surgical intervention. MST- https://microsurgical.com/ Position Objective The Design Quality Engineer will be instrumental in driving the quality assurance aspects of product design & development, from concept through to market release. This role requires a seasoned professional with a deep understanding of medical device regulations, standards, and quality management systems (QMS). A successful candidate will collaborate closely with cross-functional teams to ensure that design controls, risk management, and validation activities are effectively executed and documented in accordance with regulatory requirements. Responsibilities Lead the quality engineering activities in product development projects, ensuring compliance with ISO 13485, FDA QSR/QMSR, EU MDR and other applicable regulations and standards. Facilitate the application of design controls, including design and development planning, input, output, review, verification, validation, and transfer activities. Ensure that development activities follow design control requirements (demonstrated via Traceability Matrix), product is tested per applicable standards, ER/GSPR are met per the MDD/MDR, and product is properly transferred to manufacturing per applicable specifications. Champion risk management activities according to ISO 14971, ensuring risks are identified, evaluated, and mitigated throughout the product lifecycle. Collaborate with R&D, regulatory affairs, manufacturing, and other departments to ensure quality and regulatory requirements are integrated into the product development process. Author, review and/or approve technical documentation, including, but not limited to, design specifications, DFMEA, PFMEA, UFMEA, verification & validation protocols/reports, product labelling, equipment qualifications, and design changes, ensuring they meet regulatory and quality requirements. Lead complex root cause analysis and problem-solving activities related to product design & development and risk management. Support continuous improvement initiatives by identifying opportunities to enhance the QMS, particularly in areas related to design & development and risk management. Participate in internal and external audits and lead the resolution of any findings related to product design and development. Serve as a subject matter expert on Quality-related matters (e.g. risk management, human factors, statistical analysis) in their application to design controls, and provide guidance and training to others, as necessary. Provide expert interpretation of current and emerging regulations, standards and guidance impacting the design & development and risk management process. Assist in the preparation of submissions for regulatory agencies. Performs other duties assigned as needed. Critical Success factors In-depth knowledge of FDA QSR/QMSR, MDSAP, EU MDD/MDR, ISO 13485, ISO 14971, ISO 62366, ISO 15223, and other relevant standards and regulations highly preferred. ASQ Certification (CQE, CRE, or similar) is highly desirable. Academic qualification Bachelor’s degree in Biomedical, Mechanical, Industrial, Materials or related Engineering discipline. Experience Minimum of 3 years of experience in the medical device industry, with a strong focus on quality engineering and regulatory compliance. Key attributes Expertise in statistical analysis techniques and tools highly preferred. Proven experience in leading quality engineering activities in medical device product development, including design controls and risk management highly preferred. Competencies Detail-oriented and well-organized, with the ability to manage multiple tasks and priorities simultaneously. Excellent English oral and written communication with precise attention to detail. Strong work ethic, self-motivated, team player with strong interpersonal skills. Strong analytical, problem-solving, and project management skills. Excellent communication and interpersonal skills, with the ability to work effectively in a cross-functional team environment. Show more Show less
