Description

The Principal Design Quality Engineer reports to the Senior Director of Quality Assurance and Regulatory Affairs and actively lead Quality Assurance support for the new product development process and design transfer to manufacturing, ensuring product and process conformance to FDA Design Controls, ISO 13485:2016, ISO 14971:2012 and other applicable regulatory and technical standards. The incumbent has the ability to innovate, communicate and execute strategic regulatory plans, drive results independently and solve complex problems to meet business obligations on-time. This individual is responsible for leading Design Controls/Risk Management processes based on company objectives as well as collaborating with cross-functional departments to ensure country-specific requirements are met and integrated throughout the design control and post-product launch activities.

Essential Duties and Responsibilities

• Maintains current knowledge of relevant regulations, including proposed and final rules issued by relevant regulatory authorities that may impact the company
• Technical writing of procedures and/or SOPs that link to the international regulatory operations
• Supports the implementation of regulatory strategies and ensures timely submissions of products (EU, and ROW) in compliance with applicable regulations and guidance through coordination and preparation of submission documents for the registration of new products and changes to existing products
• Supports the preparation and compilation of regulatory information requested during government audits/inspections, such as with FDA and Notified Body
• Leads quality assurance support in the design and development/on market support of In-Vitro Diagnostics (IVD) medical device products, facilitating the application of design/change controls, risk management, quality planning and implementation of design and development plans
• Reviews and maintains risk management files such as UMFMEA/DFMEA/PFMEA that identify Hazard Analysis Critical Control Points (HACCP) and are compliant with the requirements of ISO 14971:2012
• Works closely with R&D, Manufacturing, Quality Control, and Customer Support management to prevent non-conformities and provide solutions to complex issues
• Reviews and approves proposed changes for on market products by performing risk assessments, providing guidance and support and assessing the adequacy of verifications and validations and DMR documents
• Acts as SME for key subsystems such as Design Control, Risk Management, Design Verification, Design Validation, Process Validation etc.
• Carries out duties in compliance with established business policies

Qualifications and Minimum Requirements

• Bachelor's Degree in a scientific discipline (Biology, Biochemistry, Microbiology, Chemistry,etc.) or Regulatory Affairs (RA) or Quality Assurance (QA). Advanced degree or RAC certification preferred
• Bachelor's Degree with 10+ years or Master’s Degree with 8+ years or PhD Degree with 6+ years’ Quality Assurance Engineering experience (EX: Design Controls, Change Control, Process Validation, AND/OR on Market Quality Engineering Support and Risk Management) within the In-Vitro Diagnostics (IVD) medical device industry and demonstrated ability to present and articulate requirements and influence teams
• Experience with QMS Gap Analysis, General Safety & Performance Requirements (GSPR)

Summary of Technical Documentation (STED) compilation

• Experience with the preparation/reviewing PEP/PER (APR, CPR, SVR).
• Experience with the preparation/reviewing PMSP/PMSR, PMPFP/PMPFR, PSUR, and SSP
• Experience implementing and/or maintaining quality management systems in an FDA cGMP or CE/ISO-13485 regulated industry setting 
• Experience with the preparation/updating Instructions For Use (IFU) and Safety Datasheet (SDS)
• Working knowledge, understanding and application of principles concepts and practices of government regulations, and applicable standards (e.g. ISO 13485:2016 and ISO 14971:2019)

 Preferred Skills/Abilities

• Strong analytical and organizational skills; ability for detail and precision
• Good general mathematical skills, strategies and concepts including the ability to calculate figures and amounts such as percentages
• Strong interpersonal and presentation skills with the ability to influence others in a positive and effective manner
• Experience with IVD Medical Device Immunoassay Development preferred
• Experience with Design Control (IVD Rapid Test and/or ELISA products) preferred
• Ability to organize and analyze technical data and identify issues or gaps preferred
• Strong leadership capability and technical/scientific background