The posting
Job Description
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. Provides specific quality engineering support to Risk Management, Quality improvements, Design Verification and Validation, and Design Control processes. Applies in-depth knowledge of quality engineering principals, 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, collaborating with representatives from other functional areas to facilitate risk analyses and design control processes, reviewing and approving design verification and validation documentation.
- 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 on behalf of ASP and works to build consensus on technical and quality requirements.
Education and Experience:
- Bachelor’s Degree in Engineering, Science, or other technical field. Engineering degree preferred
- At least 4 years of experience 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.
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 or microbiological method validation.
- Ability to communicate in a cross-cultural environment.
- Proficient in Microsoft Excel, Word, Powerpoint and other standard software.
- Strong working knowledge of FDA QSR 21 CFR 820 / ISO13485 quality system requirements and knowledge of both regulatory requirements and other compliance areas.
- 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
Fortive Corporation Overview
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.
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 ASP
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].
