Sr. Manager, Design Quality HW & Software

The Opportunity

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing clinical chemistry and transfusion medicine. We are more than 6000 strong and do business in over 130 countries providing answers with fast accurate and consistent testing where and when they are needed most home to hospital lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

The Role

As we continue to grow as one QuidelOrtho we are seeking a Senior Manager Design Quality (Hardware & Software). The Sr. Manager Design Quality (Hardware & Software) is a global people leader within QuidelOrtho s Global Quality & Compliance (GQ&C) organization. This leader is responsible for developing and leading a team of Design Quality professionals to ensure the design implementation and continuous improvement of Quality systems processes and programs that enable QuidelOrtho s Right to Operate and support business agility innovation and growth. This role leads a team of quality professionals that provide strategic direction and operational oversight across product design lifecycle with responsibility for overseeing Design Controls and Risk Management for hardware software and integrated IVD systems. The team also ensures that user needs requirements and claims are translated into testable scientifically sound criteria. As the primary Quality partner for cross functional development teams this role also guides the evaluation and approval of design changes drives validation and claim verification strategies and represents Quality in global audits. This role is responsible for ensuring alignment with global regulatory requirements (ISO 13485 FDA 21 CFR 820 IVDR and other applicable standards). This position requires a blend of technical expertise leadership capability and the ability to navigate complex fast paced environments while championing a proactive quality culture. The Quality & Compliance Manager/Senior Manager partners cross-functionally to embed Quality and Compliance principles throughout the product lifecycle driving harmonization inspection readiness and continuous improvement.

This leader is also accountable for developing talent strengthening scientific and compliance capabilities and fostering a culture of engagement collaboration and performance. By integrating technical expertise data-driven insights and agile leadership behaviors the Sr Manager Design Quality (Hardware & Software) ensures that Quality systems and teams deliver sustainable business and compliance outcomes.

This position will be onsite in Rochester NY.

The Responsibilities

• Establish clear priorities assign responsibilities and ensure effective resource allocation to meet business and compliance needs.

• Provide technical regulatory and operational leadership to ensure Quality systems comply with ISO 13485 FDA 21 CFR 820 IVDR and other applicable requirements.

• Drive harmonization and standardization of Quality processes procedures and tools across sites and functions to strengthen compliance and efficiency.

• Partner with R&D Regulatory Affairs Manufacturing Supply Chain and other stakeholders to integrate Quality and Compliance principles throughout the product lifecycle.

• Promote a culture of continuous improvement by identifying opportunities for simplification process excellence and digital enablement within the Quality Management System (QMS).

• Ensure the team maintains a state of inspection readiness and supports successful engagement with regulatory agencies notified bodies and internal audits.

• Monitor Quality performance using metrics and data analytics to identify risks drive root cause analysis and implement sustainable improvements.

• Coach and mentor emerging Quality team members to build organizational capability and ensure robust succession planning.

• Communicate Quality and Compliance strategy progress and risk mitigation plans to senior leadership and cross-functional stakeholders

• Perform other work-related duties as assigned.

The Individual

Required:

• Bachelors degree in Life Sciences Engineering or a related technical discipline required.

• 10 years of progressive experience in Quality Compliance or related fields within the Medical Device IVD or Biopharmaceutical industries

• Demonstrated experience leading a small to mid-sized team of professionals providing direction and oversight.

• Strong understanding of Quality System regulations and standards including ISO 13485 FDA 21 CFR 820 and IVDR.

• Demonstrated success driving Quality and Compliance initiatives that align with business strategy and regulatory expectations.

• Excellent collaboration influence and communication skills across functional and organizational boundaries.

• Strong analytical and problem-solving skills with experience using data to drive decision-making and improvement.

• Commitment to scientific integrity compliance excellence and continuous improvement.

• Strong working knowledge of Design Controls Risk Management and global regulations (21 CFR 820 ISO 13485 ISO 14971).

• Experience with software development lifecycles and relevant standards (IEC 62304 IEC 62366) is highly desirable.

• Demonstrated ability to review DHF documentation evaluate design change impacts and drive risk-based decisions.

• Hands on experience with verification validation and claim verification testing.

Preferred:

• Advanced degree (MS PhD MBA or equivalent) in a relevant discipline.

• Experience implementing or optimizing global Quality Management Systems (QMS) and digital tools.

• Lean Six Sigma PMP or similar certification demonstrating process improvement expertise.

• Experience supporting or leading Health Authority or Notified Body inspections.

• Exceptional critical thinking skills and the ability to take calculated compliant risks.

• Strong collaboration and communication skills with a proven ability to influence across matrixed teams.

Key Interactions

Internal: Operations Supply Chain R&D Commercial Regulatory Affairs GSO Quality & Compliance teams globally and regionally.

External: Regulatory agencies Notified Bodies Contract manufacturers Suppliers and service providers.

Work Environment

The work environment characteristics are representative of a manufacturing laboratory or warehouse environment.

The Physical Demands

No strenuous physical activity required. May include occasional travel for site visits leadership meetings or regulatory support.

How We Work

At QuidelOrtho our culture is shaped by four core behaviors that guide how we collaborate make decisions and support each other and those we serve. The ideal candidate will exhibit these behaviors as we believe theyre essential to how we thrive as a team and achieve meaningful impact:

• Thrive Together Collaborate intentionally grow as a team

• Make It Happen Focus on priorities embrace continuous improvement

• Commit to Service Cultivate a service mindset

• Embrace Inclusion Be open and authentic welcome diverse perspectives

Salary Transparency

Salary range for this position takes into account a wide range of factors including: education experience knowledge skills geography and abilities of the candidate in addition to internal equity and alignment with market data. At QuidelOrtho it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. Salary range for this position is $135000 to $175000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical dental vision life and disability insurance along with a 401(k) plan employee assistance program Employee Stock Purchase Plan paid time off (including sick time) and paid Holidays. All benefits are non-contractual and QuidelOrtho may amend terminate or enhance the benefits provided as it deems appropriate.

Equal Employment Opportunity

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals including individuals with disabilities have an opportunity to apply for those positions that they are interested in and qualify for without regard to race religion color national origin citizenship sex sexual orientation gender identity age veteran status disability genetic information or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability please contact us at .

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