Senior Manager, Quality Systems Design Controls Global Process Owner

As the Senior Manager Quality Systems Design Controls Global Process Owner (GPO) this role is responsible for setting the direction for Strykers company-wide Design Controls practices and processes in alignment with applicable medical device regulatory requirements. You will lead the architecture planning management and implementation of global processes documentation and systems that support our Quality Management System across divisions and locations.

This role operates in a global environment with frequent collaboration including across EMEA. Candidates based in Eastern Time hours are strongly preferred.

What you will do

• Lead the design and implementation of company-wide Design Controls processes (including packaging) and related enabling processes/technologies.

• Apply an endtoend understanding of the product development lifecycle to guide design control strategy from design planning through verification validation and design transfer.

• Establish governance and boundaries for harmonization and alignment by partnering with Corporate Division Global Quality Engineering leaders and key business partners.

• Develop input and content for Design Controls within the Global Quality Manual and Quality Management System planning activities.

• Define and drive requirements to assess Design Controls process effectiveness including packaging and manage continuous improvement actions.

• Analyze and report process performance metrics to demonstrate ongoing effectiveness and support related quality/engineering functions.

• Serve as the Design Controls process expert for acquisition integrations and post-integration remediation actions.

• Act as a primary point of contact for Corporate Office regulatory and health authority inspections related to Design Controls.

• Coach and guide Division Process Owners and hub-and-spoke teams to implement maintain and improve global processes documents and systems; resolve or escalate effectiveness/efficiency issues through leadership.

What you will need

Required

• Bachelors degree in Engineering Computer Science Software Engineering Life Sciences or a related technical discipline.

• Minimum 10 years of experience in medical device design and development within a regulated environment.

• Minimum 5 years of technical leadership supporting design engineering and/or design controls.

• Direct experience with medical device regulatory requirements.

• Experience designing governing or implementing quality system processes for regulated medical devices.

• Experience authoring and maintaining technical documentation in a regulated compliance environment.

Preferred

• Electrical or software engineering degree is a plus.

• Masters degree in engineering or engineering management.

• Experience leading multi-divisional design programs/projects across organizations and geographies.

• Experience with information systems supporting regulated development (e.g. electronic document management systems technology management software validation).

$135600 - $293700 USD Annual

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