Skip to main content
Premium Trial:

Request an Annual Quote

Manager, Assay Validation & Verification

Organization

Quidel Corporation

Job Location

9975 Summers Ridge Rd.
San Diego, CA 92121
United States

Benefits

Benefits Overview

Quidel is dedicated to offering attractive benefits that enhance employees' quality of life. These benefits are designed to offer employees a menu of options so that each employee may select benefits most meaningful to his/her personal situation. We consider our benefit plans to be an important component of total compensation for our employees.

Medical, Dental and Vision

Our employees are provided with comprehensive medical, dental and vision coverage, including prescription coverage, chiropractic, mental health, and orthodontia benefits. Employees pay a modest portion of premiums for the coverage they elect. Family coverage is available and coverage is effective on the first day of employment.

401K

Quidel's Savings and Retirement Plan (401k) gives employees the opportunity to invest for their future by allowing contributions to a variety of funds on a tax-deferred basis. To maximize an employee's retirement savings, Quidel matches 50% of employee contributions up to 6% of annual income. The maximum deferral amount an employee is allowed is governed by IRS regulations.

Tuition Reimbursement

You can receive up to $5,250 per calendar year for education/tuition reimbursement from Quidel.

Income Replacement

In order to protect employees not able to work due to illness or disability, Quidel provides income replacement programs including Sick Time, Long Term Disability, and Workers Compensation (for work incurred injuries).

Life Insurance

All Quidel employees receive a Basic Life/AD&D benefit upon hire. Additional optional Life Benefits are also available for employees, their spouse, and children.

Employee Stock Purchase Plan

Upon meeting certain eligibility requirements, Quidel employees are eligible to participate in an Employee Stock Purchase Plan. This plan allows employees to share in the success of the company by purchasing discounted stock through payroll deductions.

Flexible Benefit Spending Plan

This program allows for deductions on a pre-tax basis to pay for certain healthcare and dependent care expenses.

Vacation

Employees start accruing vacation hours upon hire. Accrual rates are based upon an employee's years of service.

Holidays

Quidel observes 11 paid holidays each calendar year.

Employee Assistance Program

All Quidel employees and members of their households are eligible to utilize a confidential Employee Assistance Program to access a variety of services including counseling and referrals to financial/legal resources.

Great Work Environment

Quidel supervisors meet with their employees at least quarterly to identify opportunities and challenges, provide performance feedback, and explore how they can help their employees grow their careers.  With a move toward increased collaboration, growth and innovation, now is a great time to work at Quidel.

Benefits Overview

Quidel is dedicated to offering attractive benefits that enhance employees' quality of life. These benefits are designed to offer employees a menu of options so that each employee may select benefits most meaningful to his/her personal situation. We consider our benefit plans to be an important component of total compensation for our employees.

Medical, Dental and Vision

Our employees are provided with comprehensive medical, dental and vision coverage, including prescription coverage, chiropractic, mental health, and orthodontia benefits. Employees pay a modest portion of premiums for the coverage they elect. Family coverage is available and coverage is effective on the first day of employment.

401K

Quidel's Savings and Retirement Plan (401k) gives employees the opportunity to invest for their future by allowing contributions to a variety of funds on a tax-deferred basis. To maximize an employee's retirement savings, Quidel matches 50% of employee contributions up to 6% of annual income. The maximum deferral amount an employee is allowed is governed by IRS regulations.

Tuition Reimbursement

You can receive up to $5,250 per calendar year for education/tuition reimbursement from Quidel.

Income Replacement

In order to protect employees not able to work due to illness or disability, Quidel provides income replacement programs including Sick Time, Long Term Disability, and Workers Compensation (for work incurred injuries).

Life Insurance

All Quidel employees receive a Basic Life/AD&D benefit upon hire. Additional optional Life Benefits are also available for employees, their spouse, and children.

Employee Stock Purchase Plan

Upon meeting certain eligibility requirements, Quidel employees are eligible to participate in an Employee Stock Purchase Plan. This plan allows employees to share in the success of the company by purchasing discounted stock through payroll deductions.

Flexible Benefit Spending Plan

This program allows for deductions on a pre-tax basis to pay for certain healthcare and dependent care expenses.

Vacation

Employees start accruing vacation hours upon hire. Accrual rates are based upon an employee's years of service.

Holidays

Quidel observes 11 paid holidays each calendar year.

Employee Assistance Program

All Quidel employees and members of their households are eligible to utilize a confidential Employee Assistance Program to access a variety of services including counseling and referrals to financial/legal resources.

Great Work Environment

Quidel supervisors meet with their employees at least quarterly to identify opportunities and challenges, provide performance feedback, and explore how they can help their employees grow their careers.  With a move toward increased collaboration, growth and innovation, now is a great time to work at Quidel.

 

 

Job Description

The Manager, Assay V&V plays a crucial role in the management, planning, resourcing and execution of verification and validation activities across various assays on multiple platforms. The Manager also provides oversight and guidance to the Assay V&V Team. The position is responsible for verification and validation of new Assays and consumables, across all platforms as well as requirements reviews, verification and validation/test planning, study execution and reporting.

The Assay Verification and Validation Manager works with multiple groups, including Project Management, Research and Development, Quality, Regulatory, Marketing, and various other business departments. This person defines the goals and objectives of the Assay V&V Department by developing and managing plans, protocols, data, and reports as they relate to Assay V&V efforts. The Assay V&V manager ensures that the assay verification and validation processes are understood and appropriately used during implementation and issues are escalated/resolved in a timely manner. In addition, the Assay V&V Manager reviews processes for quality improvements, ensures that identified improvement initiatives are completed and leads all analytical verification and validation activities related to Regulatory submissions. 

ESSENTIAL FUNCTIONS

  • Manages the creation of verification and validation processes and documentation for assay and consumable changes and executes associated testing.
  • Manages preparation of verification and validation protocols and reports.
  • Generates design verification and validation project plans.
  • Contributes to Assay and component risk management deliverables.
  • Ensures that post-launch design control documentation conforms to internal procedures and medical device regulations and standards as part of ECO processing.
  • Manages overall assay verification including documentation of all products both under development and released.
  • Trains, develops, and coaches staff to continuously improve their knowledge, productivity and effectiveness in assay and consumable verification and validation activities.
  • Provides cross-functional support as needed to address Quidel Assay queries or complaints from the field.
  • Works with R&D personnel to evaluate new technologies and improvements to existing technologies as used within Quidel Assay products.
  • Authors and manages the execution of Validation protocols to ensure compliance and adherence with corporate policies, procedures, guidelines, and compliance regulations.
  • Authors summary reports for executed verification protocols
  • Guides testing and compliance efforts to ensure regulatory, quality, and safety priorities are adequately addressed.
  • Participates in requirements gathering for user, functional, and system requirements.
  • Maintains oversight of the user, functional, and system requirements to meet the testing objectives while managing a traceability matrix to verify all testing is conducted and properly documented.
  • Supports V&V approaches and requirements during audits.
  • Maintains a safe working environment based on established procedures.

Requirements

EDUCATION & EXPERIENCE

  • Bachelor’s Degree in Engineering, Science, related field or equivalent.
  • 10+ years of relevant experience in a pharmaceutical or medical device environment. ISO13485, ISO 62304 and FDA QSR experience. Typically, 5 years of management experience with a V&V Group or a combination of project management, V&V and R&D experience.
  • Experience implementing or managing post-launch design changes to Assays across all platforms.
  • Experience in software product development and test. 

SKILLS & EXPERIENCE

  • In depth knowledge of FDA guidelines relevant to 21 CFR Part 11 compliance requirements including 510(k) and PMA submissions.
  • Ability to translate compliance priorities effectively and efficiently into design, testing, documentation, and project objectives.
  • Experience in development and implementation of standards, procedures, and guidelines in support of validated operational processes.
  • Knowledge of FDA design control requirements.
  • Ability to clearly articulate design verification and validation process concepts to the business community through written and oral presentations.
  • Good organizational skills, and the ability to manage multiple tasks
  • In depth knowledge of product development tools and processes (e.g., Design Input, Design Output, Verification and Validation, Product Risk Management, Change Control)
  • Strong analytical and problem-solving skills
  • Knowledge of related quality systems regulations and processes
  • Ability to work within cross-functional teams
  • Strong communication skills, written and verbal
  • Must exhibit professionalism, confidence, maturity, desire to succeed, proactive and self-motivated
  • Appropriate office computer skills (e-mail, word processing, statistical, spreadsheet and graphing software)

About Our Organization

Quidel Corporation is a  is a leading manufacturer of diagnostic solutions at the point of care, delivering a continuum of rapid testing technologies that further improve the quality of health care throughout the globe. An innovator for over 40 years in the medical device industry, Quidel pioneered the first FDA-cleared point-of-care test for influenza in 1999 and was the first to market a rapid SARS-CoV-2 antigen test in the U.S. Under trusted brand names Sofia®, Solana®, Lyra®, Triage® and QuickVue®, Quidel’s comprehensive product portfolio includes tests for a wide range of infectious diseases, cardiac and autoimmune biomarkers, as well as a host of products to detect COVID-19. With products made in America, Quidel’s mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of our families, our communities and the world.