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).

Requirements

Must-haves

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.
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.
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.
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.
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.

Nice-to-haves

Bachelor’s Degree in Engineering, Science, or other technical field. Engineering degree preferred

Application prep

Use the role’s language and application details while tailoring your materials.

Platform: oracle-cloud
Effort: medium