Senior Manager, Global Design Assurance

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Reporting to the Vice President of Quality, the Sr. Manager of Design Assurance, will lead and build a dynamic medical device design assurance team focused on standardizing and deploying best in class processes that include the design and development of embecta's diabetes care medical device worldwide. This person will lead the engagement and interaction with key internal customers specifically R&D, Quality Systems, Regulatory Affairs, Operations Quality, and Post Market Surveillance teams along with key external customers.

This leader will drive alignment on quality related processes, targets, and goals. You will be a member of the global quality senior leadership team and support and lead global initiatives and ensure successful outcomes for global quality initiatives and programs. This role is crucial in overseeing and driving sustaining projects for the existing product portfolio and will play a key role in ensuring ongoing product quality and compliance.

The primary responsibilities include enhancing design quality assurance processes, spearheading quality engineering and design assurance initiatives, and collaborating with cross-functional teams to foster continuous improvement.

RESPONSIBILITIES:

The Senior Manager of Design Assurance will be responsible for leading and managing the following activities:

• Lead the implementation and governance of design control processes in compliance with quality standards such as 21 CFR 820.30, ISO 13485, and ISO 14971.
• Champion the development and maintenance of risk management files per ISO 14971, ensuring complete traceability from hazard identification to risk mitigation and post-market surveillance.
• Act as the quality voice in design reviews, ensuring that Critical to Quality attributes are defined, validated, and monitored.
• Implement Design for Reliability (DfR) and Design for Manufacturability (DfM) principles in collaboration with R&D, Operations and Supply Chain for embecta product.
• Improve the change control process by streamlining procedures and processes to ensure thorough documentation and communication of changes.
• Implement quality improvement initiatives. Initiatives should focus on enhancing quality compliance, efficacy and safety of embecta’s products by streamlining processes, and reducing process defects or non-conformities.
• Establish excellent working relationships with quality, R&D, operations, regulatory, and commercial teams to ensure successful transitions from product development projects into commercial operations.
• Collaborate with suppliers to ensure the quality of materials and components used in product development.
• Engenders cooperation between teams to enable issue resolution
• Serve as a facilitator and mentor to subordinates and fellow co-workers, retain/build organizational talent
• Successfully mentor and develop the design assurance team by providing training, guidance, and support, fostering a collaborative and innovative work environment

People Manager Core Competencies

The ideal candidate will develop talent with integrity, transparency, and a focus on measurable outcomes. They will incorporate external perspectives, foster creativity, and collaborate effectively, ensuring inclusivity and continuous improvement. In organizational design and succession planning, they will maintain ethical standards, adapt to industry trends, and engage team members, promoting a culture of inclusivity. Effectively carries out the expectations of People Managers as defined in company’s people leadership expectations.

Among others this includes maintaining regular, at a minimum once a month, and transparent communication with the team through effective use of formal one-on-one meetings with direct reports and team meets. Managing performance issues and conflict proactively uses judgement in consulting with department leadership and Human Resources. Responsibility for the team´s compliance in terms of training, and…