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About the Role

This role is responsible for defining, owning, and continuously improving the end-to-end requirements and specifications framework for a portfolio of assay-based medical device products. The Quality Lead establishes standardized processes, templates, and best practices to ensure product, system, and manufacturing requirements are clear, traceable, compliant, and fit for purpose across the entire product lifecycle, embedding Quality and Compliance principles throughout.

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 Manufacturing, R&D, Regulatory Affairs, 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.

Requirements

Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline.
7+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries.
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.
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.

Skills

Requirements management
Specifications management
Quality systems
Compliance
ISO 13485
FDA 21 CFR 820
IVDR
Product lifecycle management
Cross-functional collaboration
Data analysis
Problem-solving
Process improvement
QMS optimization
Digital tools implementation

Location

Onsite at any major site

Work Type

Onsite
Full-time

Experience Level

7+ years of progressive experience

Education Level

Bachelor's degree in Life Sciences, Engineering, or a related technical discipline
Advanced degree (MS, PhD, MBA, or equivalent) in a relevant discipline

Salary/Compensations

$135,000 to $175,000 and is bonus eligible

Benefits

Medical insurance
Dental insurance
Vision insurance
Life insurance
Disability insurance
401(k) plan
Employee assistance program
Employee Stock Purchase Plan
Paid time off (including sick time)
Paid Holidays

About the Company

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 6,000 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.

Equal 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 recruiting@quidelortho.com.