Job summary
Job post source
This job is directly from QuidelOrtho
Job overview
The Senior Verification and Validation Engineer (Lead) at QuidelOrtho leads the verification and validation of complex medical devices, ensuring regulatory compliance and product quality in a critical role within the engineering team.
Responsibilities and impact
The role involves managing V&V resources, designing and executing manual test procedures, analyzing test results, documenting defects, leading team meetings, collaborating with software development, and mentoring team members to ensure successful product launches and lifecycle maintenance.
Compensation and benefits
The salary range is $95,000 to $110,000 with bonus eligibility, and includes comprehensive benefits such as medical, dental, vision, life, disability insurance, 401(k), employee assistance, stock purchase plan, paid time off, and holidays.
Experience and skills
Requires a B.S. or M.S. in relevant fields and 10+ years of experience, preferably in medical devices, with strong knowledge of software configuration, defect tracking, V&V theory, FDA regulations, quality systems, and test cycle management; strong analytical, organizational, communication skills, and ability to work cross-functionally are essential.
Career development
The position offers opportunities to lead and mentor within a collaborative engineering team, contributing to professional growth through project leadership and cross-functional interactions.
Work environment and culture
QuidelOrtho prioritizes employee happiness, engagement, and meaningful connections, fostering a supportive and inspiring work environment focused on transforming diagnostics for a healthier future.
Company information
QuidelOrtho is a global leader in in vitro diagnostics formed by the merger of Quidel Corporation and Ortho Clinical Diagnostics, with over 6,000 employees and operations in more than 130 countries, specializing in immunoassay, molecular testing, clinical chemistry, and transfusion medicine.
Team overview
The candidate will join a collaborative engineering team responsible for V&V activities, working closely with software development, marketing, quality, and project management teams.
Job location and travel
This is a 100% onsite position at 100 Indigo Creek Drive (CNP location), with about 10% travel involving air and ground transportation and overnight stays.
Unique job features
The role involves working in a BL2 lab environment with exposure to viral, bacterial hazards, and potentially infectious materials, requiring adherence to strict safety and regulatory standards, and offers flexible work hours to meet project deadlines.
Company overview
QuidelOrtho Corporation is a leading global provider of diagnostic testing solutions, specializing in immunoassays, molecular diagnostics, and clinical chemistry. The company generates revenue by developing and selling innovative diagnostic products and services to healthcare providers, laboratories, and hospitals worldwide. Formed from the merger of Quidel Corporation and Ortho Clinical Diagnostics in 2022, QuidelOrtho combines decades of expertise and a broad portfolio of diagnostic technologies to enhance patient care and improve health outcomes. The company is known for its commitment to quality, innovation, and customer service.
How to land this job
Position your resume to highlight leadership in verification and validation within medical device environments, emphasizing your experience managing V&V resources and bridging software development with testing teams.
Focus on showcasing your knowledge of FDA regulations, IEC 62304, ISO 13485, and ISO 14971 standards, along with your expertise in writing test plans, test cases, and managing defect tracking.
Apply through QuidelOrtho's corporate careers site as well as LinkedIn and other job boards where the position is posted to maximize your application visibility.
Connect on LinkedIn with current employees in QuidelOrtho’s Instrument Verification and Validation or Software Development teams; start conversations by commenting on recent company innovations or asking about team culture and project challenges.
Optimize your resume for ATS by including keywords such as 'Instrument V&V,' 'FDA QSR,' 'design control documentation,' 'test procedure development,' and 'software defect management' to ensure it passes automated screenings.
Leverage Jennie Johnson’s Power Apply feature to automatically tailor your resume, identify multiple application platforms, and find relevant LinkedIn contacts to network with, saving you time and increasing your chances of landing the role.
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