Senior Quality Assurance Engineer
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 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.
The Role
As we continue to grow as QuidelOrtho, we are seeking a Senior Quality Assurance Engineer. The purpose of this position is to professionally interact and participate in the design and execution of all quality related deliverables per Quidel Quality Management System to support new product development.
Drive product / process improvements through leading / assisting Corrective Action / Preventive Action activity. Provide direction and training to team members for Risk Management and other cross functional Quality type procedures and processes to support new product development.
Carries out other duties as assigned in compliance with established business policies.
This position will be located onsite in San Diego, CA
The Responsibilities
Responsibilities include supporting new product design / development activities utilizing internal and external quality derived industry standards.
The incumbent may also lead corrective action / preventive action projects.
Administering Master Validation Plans (MVP)
Develop Risk Management File
Develop new product design trees
Generate Change Orders as required to support New Product Development and / or corrective / preventive action projects.
Monitor Development Trace Matrix requirements
Determine experimental sampling plans
Assist in transitioning product from development to manufacturing
Develop qualification test plans for new raw materials, injection molded parts and manufacturing equipment
Assist in development of raw material, production material and product specifications
Summarize experimental data and draw conclusions.
Maintain project documentation in accordance with internal Quidel and external regulatory requirements as part of the design control process.
Active participation with corrective action / preventive action projects in accordance with Quidel’s Quality Management System.
Assist in maintaining the Quality Management System
Maintain a safe working environment.
The Individual
Required Skills :
Must have experience as a Quality Engineer : 5+ years
Must have experience as a Quality Engineer on new product development : 3+ years
Must have experience working and managing time lines / deliverables. BA / BS in Scientific field required, QE certification desired.
New product development design control processes
Project planning
Strong analytical and problem solving skills
Good organizational skills, and the ability to manage multiple tasks
Experience in experimental design
Ability to work within cross functional teams
Strong communication skills, written and verbal
Must exhibit professionalism, confidence, maturity, desire to succeed and be proactive / self-motivated
Strong knowledge of relevant Quality and analytical tools
Ability to participate in planning and managing project deliverables
Working knowledge of manufacturing tools and processes (i.e. BOM, Routings, SPC Charts, Risk Management, Quality Test Plans and Master validation plans)
Knowledge of related quality systems regulations and processes
Appropriate computer skills (e-mail, word processing, statistical, spreadsheet and graphing software)
The Key Working Relationships
Internal : R&D, Engineering, Quality, Operations and Regulatory, Supplier Quality Engineers, Process Engineers and Manufacturing Quality Engineers
External : Vendors and contractors
The Work Environment
The work environment characteristics are representative of both an office and manufacturing environment. Flexible work hours to meet project deadlines.
Occasional travel required. Travel includes airplane, automobile travel and overnight hotel.
Essential functions are subject to change as other duties may be assigned.
Position requires ability to lift up to 30 lbs. on a regular basis. Typically 40% of time in meetings (attend ADHOC meetings is essential to this position);
60% of time at the desk on computer / doing paperwork / on phone, doing analytical work. Walking, standing, and sitting for long periods of time are routine to accomplish tasks in this role.
Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Must be able to visually monitor products for Quality Standards.
Position may be required to use Personal Protective Equipment as posted.
Salary Transparency
The 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 the facts and circumstances of each case.
The salary range for this position is $78,600.00 - 145,000.00. 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.
Manager, Manufacturing
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 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.
The Role
As we continue to grow as QuidelOrtho, we are seeking a Manager, Manufacturing. Under minimal supervision, this position is responsible for management of manufacturing, assembly, and production departments and personnel by providing guidance, training and leadership on a daily basis.
Position may be part of multi-shift supervisor team empowered to manage 24 hour manufacturing operations.
This position will be located onsite in San Diego, CA.
The Responsibilities
Responsible for managing and monitoring assembly preparation, device assembly, meter preparation and calibration, and / or packaging areas
Establishes manufacturing policies and procedures
Develops and recommends project objectives, timelines and resources, and prepares cost estimates
Manages departmental budgets and spending
Uses problem analysis techniques to resolve production-related, technical, regulatory, quality, and supply issues
Represents the department or leads cross-functional teams aimed at resolving issues, and implementing projects.
Reviews complaints and suggestions, and recommends methods or techniques for improvement
Ensures personnel are trained and qualified in manufacturing procedures
Demonstrates commitment to the development, implementation and effectiveness of Quidel’s GMP, LEAN, and Safety programs.
Ensures compliance with FDA, ISO, OSHA, and other regulatory agencies
Manages performance of staff towards department and Company goals, including but not limited to feedback on performance, appraisals, recommendations for merit increases or necessary disciplinary actions, communication to employees on performance.
Carries out duties in compliance with established business policies
Performs other duties & projects as assigned
The Individual
Required Skills : High School Diploma
High School Diploma
Eight years of experience in manufacturing required, preferably in the biotechnology industry
Excellent skills in MS Office (MS Word / Excel)
Excellent Good Manufacturing Practice (GMP) knowledge
Experience in understanding and adhering to manufacturing documentation, and completing manufacturing documentation
Experience in managing the operation of equipment and conduct tasks in a safe manner, adhering to established guidelines and applicable regulations
Strong technical writing and analytical skills required to write investigative reports, SOPs, NCMRs, batch records and other production-related documents
Demonstrates commitment to the development, implementation and effectiveness of Quidel Quality Management System per ISO, FDA and other regulatory agencies
Understands and is aware of the quality consequences which may occur from the improper performance of their specific job.
Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities
Preferred Skills :
Bachelor’s degree in production, life science or equivalent or a combination of courses and experience
Four years of experience in a management position overseeing supervisors and staff
The Key Working Relationships
Internal : R&D, Supply Chain, Production Managers, Planning, Cost Accounting, Facilities ,Process Engineers and Quality Engineers.
External : Supplier, Vendors and contractors
The Work Environment
The work environment characteristics are representative of office, laboratory, and manufacturing environment and may include handling of viral and bacterial hazards as well as infectious or potentially infectious bodily fluids, tissues and samples.
Flexible work hours to meet project deadlines.
Position requires ability to lift up to 30 lbs. on occasion. Up to 60% of time in meetings, working with team and on the manufacturing floor;
40% of the time at the desk on computer, walking, standing or sitting extended periods of time, doing analytical work are routine to accomplish tasks in this role.
Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Position requires use of Personal Protective Equipment as posted.
Salary Transparency
The 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 the facts and circumstances of each case.
The salary range for this position is $85,000.00 - 150,000.00. 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.