CDx Lead - Quality Engineering
Edison-New Brunswick Metro Area, NJ
Responsible for owning and implementing design control within the device and combination product space and ensuring collaborative partners and external suppliers are compliantly operating to the requirements.
The Quality Engineering Lead supports the development of new products through participation in cross functional product teams and ensuring process conformance to global standards and regulations.
This position will have responsibility for the creation and accuracy of developmental documentation, ensuring the integrity and accuracy of data from feasibility studies through process development and final process characterization in support of regulatory submissions.
In this role, the Lead will own Design History File deliverables, author development documentation strategies, facilitate risk analyses and provide general technical engineering support throughout new product development and lifecycle projects. The role will be responsible for building a team of engineers tasked with providing direct project team support.
Requires Advanced Degree and a Minimum 10 years relevant work experience, specifically in the regulated healthcare space (pharmaceutics, biologics or medical devices). Minimum 5 years of leadership experience.
- Knowledge of drug substance, drug product, primary containers, container closure systems and drug delivery devices.
- An understanding of end-to-end device and combination product design attributes including: packaging, sterilization, biocompatibility, drug-device compatibility and fill/finish.
- General knowledge of the regulatory and compliance requirements for design controls and combination products (21 CFR Part 4, 21 CFR Part 820, ISO 13485 and ISO 14971, 93/42/EEC).
- Awareness of pharmaceutical and biologic regulations and standards including 21 CFR Part 210, 21 CFR part 600, 2010/83/EC and relevant ICH guidelines.
- Knowledge of Risk Management and statistical analysis tools (e.g. Six Sigma, Risk Analysis, FMEA, etc.)
- Ability to identify problems, review related information, develop and evaluate options, and implement solutions
- Skilled oral and written communicator
- Ability to work in a cross-functional, matrixed environment.
- Experience with companion diagnostics is highly preferable.
- DUTIES AND RESPONSIBILITIES
- Design Control
- Business owner for all aspects of Design Control for device and combination product development including CDx. This includes requirements flow-down (user requirements-design inputs-design outputs), vendor controls, verification, validation and design transfer.
- Serve as an SME related to Design Control and Device QMS within company and during interactions with external vendors/third-parties.
- Assist in the development and lifecycle management of procedures and systems including Design Controls, Risk Management, Requirements Management, Development Documentation and Stage Gate Deliverables.
- Participates on teams to ensure robust application of appropriate controls in the design, development, qualification and commercialization phase of product development.
- Supports application of policies and processes in collaboration with external manufacturers, CMOs and CROs.
- Leads Risk Management activities on product development teams and owns the final Risk Management Report (RMR).
- Provides SME guidance to development teams on topics related to developmental documentation, data accuracy, data integrity and good documentation practices.
- Engages in continuous improvement activities by identifying opportunities and recommending improvements to design and development process.
- Applies scientific theories and technical principles to solve problems of moderate complexity with minimal oversight.