Senior Global Design Assurance Manager:
The Global Design Assurance Manager has the responsibility to assure the quality of product design from development through manufacture and commercial distribution for all new and upgrade products developed within the business unit. The successful incumbent will assure product designs provide the necessary safety, efficacy, regulatory compliance and customer satisfaction while balancing the need for speed to market for new innovations as well as cost effectiveness. A key accountability of this role is the ability to identify, assess and mitigate risks in the design of products that have the potential to result in significant business disruption including product recalls and product liability issues. The role must develop and deliver a robust system of Design Controls and build a talented team of design quality professionals that can work effectively with the R&D and Regulatory functions to execute design excellence. The Design Assurance Manager is responsible to develop and implement a design quality strategy that supports the overall quality strategy as well as the key Business goals.
Responsibilities and Duties
Responsible for implementing and maintaining the effectiveness of the Design Controls system across IDEM Manufacturing plants.
- Direct the IDEM Design Assurance organizations based in our Asia/European manufacturing sites.
- Develop and execute strategies to optimize Design Controls process within IDEM and ensure compliance and connectivity to the broader Abbott design assurance process requirements.
- Provide design assurance oversight to all functions operating in the New Product Introduction area.
- Define clear roles and responsibilities for all functions to ensure effective execution of the design controls process (R&D, RA, PM, Operations, Clinical).
- Ensure timely communication with VP of QA and Senior Leaders on critical design quality
- issues that arise at any stage of the product design process.
- Manage resources to support product launches, appropriately matching skill set of individual direct reports to demands of projects, prioritizing efforts, anticipating technical issues and assuring successful project outcomes.
- Conduct/Coordinate regular and robust design reviews that provide assessment of issues, risks, and resource requirements for all phases of NPI projects.
- Ensure that product/process/package/label/Test Method designs and associated documentation comply with applicable Regulations for products distributed globally (US/OUS).
- Pro-actively monitor Post Market surveillance trends to ensure any potential design issues are addressed as well as developing a closed loop feedback system to the design process.
- Work closely with the R&D and Design Quality teams to ensure robust new product launch planning and successful design transfer process.
- Design Controls SME and person directly responsible to represent IDEM with outside Regulatory authorities (FDA, NMPA, Notified Bodies, MoH, WHO) on design quality.
- Participate in Regulatory Agency inspections and respond to queries related to product design controls, change control and complaints.
- Collaborate with Regulatory Affairs and R&D to establish appropriate product filing strategies and provide necessary product documentation for submission.
- Establish and execute design control policies, procedures, processes and principles to ensure robust product designs, appropriate evaluation during development and document change controls compliant with requirements.
- Collaborate with R&D in the development of Design test protocols and study plans and ensure both test plans and reports are compliant with all applicable regulatory requirements.
- Work with R&D to ensure that Product Test Methods are designed to provide the appropriate challenge to products and validated appropriately.
- Work with R&D to ensure successful and cost-effective product scale-up and technology transfer from R&D to commercial manufacture.
- Establish a post launch review process that monitors new product performance against the expected market performance and triggers escalation/intervention as necessary.
- Develop design assurance processes, systems, and Staff, delivering a high performing team that supports successful NPI execution across all Sites.
- Bachelor’s Degree – Engineering/Science/Life Sciences - Post graduate degree desirable.
- Job requires extensive knowledge of Medical Devices and/or IVD design and manufacturing as well as experience in a fast moving R&D environment.
- Experience managing a design assurance team is essential and preferably experience working with teams remotely.
- Proven track record of results managing projects in a highly regulated environment.
- Strong Leadership capability and ability to influence change balancing compliance with pragmatic problem solving.
- Proven track record in delivering successful NPI programs on budget and on time.
- Proven track record in delivering Continuous Improvement programs.
- Must have strong technical ability and be articulate in message delivery.
- Ability to work and interact with several cultures across various time zones.
- Experience managing in an environment with changing priorities and making appropriate risk based decisions in the face of uncertainty.
- Excellent written and verbal interpersonal skills to influence many diverse internal and external stakeholders.
- Ability to present complex technical information to Senior Management.
- 5 years plus experience in a QA/R&D 0r other Technical leadership role in a regulated environment.