Senior Product Quality Engineer

Senior Product Quality Engineer

Job Function: Engineering

Job Family: Quality Assurance Engineering

Business Label: Design

Reports to: Manager, Product Quality (India)

Location: Bangalore, India

Working Type: Hybrid

At ASP, we believe in you. We believe in your potential - your ability to learn, grow, and contribute in meaningful ways. We believe in the power of great people working together to innovate and solve problems no one could solve alone. We build enduring partnerships with our customers and take on their challenges and opportunities as our own.

Job Summary

Provides design quality engineering guidance and support for New Product Introduction (NPI) and/or Product Life Cycle Management (LCM) activities, with a focus on product quality while ensuring compliance to company-wide Quality Management System and regulatory requirements for life science products (electro-mechanical devices, software, hardware, biocides, detergents, biological and chemical indicators). Provides specific quality engineering support to New Product Development, Quality improvements, Design Verification and Validation, Design Control, and Risk Management processes. This includes ownership of risk management deliverables, the pathway from field signals to design inputs and their tracked implementation, for both internally and externally designed products. Applies in-depth knowledge of quality engineering principles, relevant regulations, standards, industry best practices, and other related disciplines to assignments. Independently plans and executes complex projects and assignments within broad guidelines, exercising judgment based on analysis of multiple sources of information. Receives minimal guidance and acts as a resource for colleagues with less experience.

Key Responsibilities:

• Owns the Risk Management process and deliverables (hazard analysis, DFMEA/SWFMEA, software hazard analysis, risk control verification, and the Risk Management File/Report per ISO 14971), collaborating with representatives from other functional areas to facilitate risk analyses and design control processes, reviewing and approving design verification and validation documentation.
• Owns the complaint-to-design-input pathway as the Design Quality liaison between Customer Quality and Design Engineering to ensure field signals (complaint trends, service data, post-market surveillance and CAPA outputs) are assessed against the risk file, translated into design inputs (design, software, labelling or documentation changes), and tracked through implementation and verification of effectiveness; drives related process improvements.
• Performs complex technical investigations including formal NCs and CAPAs coordinating cross-functionally to ensure sound experimental design, effective analysis of multiple sources of information, appropriate risk analysis, design control, and verification and validation, and timely investigation closure.
• Acts as a resource for colleagues in risk management, design control, verification and validation, or CAPA and supports new product introduction, design changes, and post-launch activities.
• Provides training and informal guidance on quality management system elements to colleagues with less experience and representatives from other functional areas.
• Uses best practices and knowledge of internal and external business issues to identify and recommend improvements to quality systems, products, and processes in alignment with quality and business objectives.
• Supports and participates in cross-functional projects and may lead small projects with manageable risks and resource requirements.
• Contributes technical improvements that enhance quality systems and support business goals. Applies appropriate tools and methods (e.g. 6-Sigma, Lean, Statistical methodologies) to improve products, processes, and services.
• Participates in technical reviews, explains difficult or sensitive quality information, and works to build cross-functional consensus.
• Ensures quality control plans are commensurate with product risk and consistently followed across own and related teams.
• Communicates business-related issues and opportunities to the next management level and recommends appropriate actions within the role's scope.
• Supports internal, external, and third-party audits as Quality Subject Matter Expert and responds to observations in support of compliance with quality management system elements.
• Provides back-room support for third-party inspections and audits, such as Registrar, Notified Body, FDA, or customer audits.
• May interface during audits with regulatory agencies or customers.
• May interface with contract laboratories or external design/development partners on behalf of ASP and works to build consensus on technical and quality requirements.

Education and Experience:

• Bachelor’s degree in engineering, Science (Biology, Microbiology, Chemistry, etc.) or other technical field. Engineering degree preferred.
• At least 5-8 years of experience preferred in Quality Assurance, Quality Engineering, or related field.
• Minimum 3 years quality engineering experience in FDA or other regulated industry (medical device, pharmaceutical, aerospace, etc.) or equivalent; medical device preferred.

Role and Competencies Requirements:

• Outstanding business and technical communication skills (verbal, written, presentation).
• Experience planning and executing projects, including small projects with manageable risks and resource requirements, critical path analysis, and analytical, microbiological, or hardware/software test method validation.
• Ability to communicate in a cross-cultural environment.
• Proficient in Microsoft Excel, Word, PowerPoint and other standard software.
• Preferred: familiarity with requirements/test management and defect tracking tools (e.g. Jira/Xray/DOORS) and statistical and/or other data analysis software.
• Strong working knowledge of FDA QSR 21 CFR 820 / ISO 13485 quality system requirements and knowledge of both regulatory requirements and other compliance areas; working knowledge of IEC 62304, ISO 14971, IEC 62366-1 and the IEC 60601 series preferred.
• Ability to effectively prioritize and manage multiple activities and responsibilities.
• Demonstrated proficiency in Risk Management, FMEAs, Design Control, Root Cause, and Design Verification and Validation methodologies.
• Conceptual and practical expertise in quality engineering, with basic knowledge of related disciplines and an understanding of how the quality function integrates with Operations, R&D, Field Service, Suppliers, Finance, and Marketing/Sales.
• Demonstrated ability to work effectively across functions, build consensus, act as a resource for colleagues with less experience, and lead small projects with manageable risks and resource requirements.
• Knowledge of Quality Engineering and Scientific methods (method development, method validation, method transfer), statistical analysis tools, and other techniques.
• Fundamental technical understanding of manufacturing equipment and processes.
• Ability to work independently with minimal guidance and within broad guidelines and policies.
• Ability to explain difficult or sensitive information, build consensus, and interact effectively with peers, colleagues, and stakeholders. Self-motivated.
• Travel: Domestic up to 15%
• Lifting requirement: Medium (16-30 lbs).

About Us

ASP is a leading global provider of innovative sterilization and disinfection solutions, and a pioneer of low-temperature hydrogen peroxide sterilization technology.

ASP's mission is to protect patients during their most critical moments. We support healthcare facilities in the fight to protect patients against hospital acquired infections, which are a leading cause of morbidity and mortality. ASP's products, which are sold globally, include the STERRAD system for sterilizing instruments and the EVOTECH and ENDOCLENS systems for endoscope reprocessing and cleaning.

Fortive's essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance, industrial condition monitoring, next-generation product design, and healthcare safety solutions.

We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in software-powered workflow solutions, data-driven intelligence, AI-powered automation, and other disruptive technologies. We're a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to groundbreaking sustainability solutions.

We are a diverse team 18,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact.

The company in which you have expressed employment interest is a subsidiary or affiliate of Fortive Corporation. The subsidiary or affiliate is referred to as a Fortive Company. Fortive Corporation and all Fortive Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, ancestry, sex (including pregnancy, childbirth and related medical conditions), age, marital status, disability, veteran status, citizenship status, sexual orientation, gender identity or expression, and other characteristics protected by law.

At Fortive, we believe in you. We believe in your potential-your ability to learn, grow, and make a difference.

At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone.

At Fortive, we believe in growth. We're honest about what's working and what isn't, and we never stop improving and innovating.

Fortive: For you, for us, for growth.

Ready to move your career forward? Find out more at careers.fortive.com.

Fortive Corporation Overview

Fortive's essential technology makes the world safer and more productive. We accelerate transformation in high-impact fields like workplace safety, build environments, and healthcare.

We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in healthcare sterilization, industrial safety, predictive maintenance, and other mission-critical solutions. We're a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to advanced technologies that help providers focus on exceptional patient care.

We are a diverse team 10,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact.

At Fortive, we believe in you. We believe in your potential-your ability to learn, grow, and make a difference.

At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone.

At Fortive, we believe in growth. We're honest about what's working and what isn't, and we never stop improving and innovating.

Fortive: For you, for us, for growth.

About Advanced Sterilization Products

ASP is a leading global provider of innovative sterilization and disinfection solutions, and a pioneer of low-temperature hydrogen peroxide sterilization technology.ASP’s mission is to protect patients during their most critical moments. We support healthcare facilities in the fight to protect patients against hospital acquired infections, which are a leading cause of morbidity and mortality. ASP’s products, which are sold globally, include the STERRAD system for sterilizing instruments and the EVOTECH and ENDOCLENS systems for endoscope reprocessing and cleaning.

We Are an Equal Opportunity Employer. Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment application process, please contact us at [email protected].

Bonus or Equity

This position is also eligible for bonus as part of the total compensation package.