Quidel Jobs (2)

Senior Quality Assurance Engineer

Quidel San Diego, CA
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JOB DESCRIPTION

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, strong and do business in over 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,.00 - ,.00. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a (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.

LI-AH1

Full-time
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Manager, Manufacturing

Quidel San Diego, CA
APPLY

JOB DESCRIPTION

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, strong and do business in over 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 - ,.00. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a (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.

LI-AH1

Full-time
APPLY