Job description
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. We are a leading manufacturer of point of care diagnostic solutions. 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.
We are excited to announce that Quidel Corporation is now becoming QuidelOrtho! This transaction will bring together two world-class teams and complementary product portfolios to serve patients around the world. During this transition period, we encourage you to continue visiting our career site and also check out more career opportunities at Careers at Ortho Clinical Diagnostics | Ortho Clinical Diagnostics jobs Join our journey as we become one global diagnostics leader!
This position is responsible for the successful transfer of new products from R&D into manufacturing which requires the ability to develop appropriate acceptance criteria for product transfer. The Sr. Quality Engineer, New Products ensures that quality tools such as Failure Mode and Effects Analysis (FMEA) and Manufacturing Control Plans are effectively determined and implemented prior to product transfer. The position acts as a key member of Quidel’s Validation Review Committee by evaluating changes to existing products, assessing the acceptance criteria, and ensuring no adverse impact on product performance. This role plays an integral part with Quidel’s product and process validation system and supports Quidel’s Technical Support and Marketing teams by providing technical assistance related to product expectations and other quality considerations.
#LI-AH1
ESSENTIAL FUNCTIONS:
- Ensure FMEAs for new and existing products are robust and complete. Continually review and update FMEAs as failure modes are identified
- Ensure the control points proposed through the design and development process are evaluated for adequacy as related to field performance and manufacturability
- Support escalations related to stability study of new product launches and/or changes to existing product or regulations
- Participate in Complaint Committee meetings and present investigation findings to peers and management
- Represents the Quality Control department in evaluating readiness for product launch.
- Perform statistical analysis of data from experiments and manufacturing process trend monitoring
- Participate in New Product team meetings and Validation Review Committee meetings (VRC).
- Support and lead complex root cause failure investigation and troubleshooting of customer complaints and product nonconformances within manufacturing
- Monitor field complaint data to evaluate new product performance and the impact of changes
Education and Experience
- B.S. in Engineering/Chemistry/Biology/Technical Discipline or equivalent combination of certification and work experience preferred
- 6-8 years’ experience in Quality and Manufacturing Systems in Medical Device and high-volume manufacturing environments required
- Minimum 3 years’ experience in New Product introductions preferred
- ASQ Quality Engineer Certification (CQE) preferred
Knowledge/Skills
- Quality Engineering skills which includes FMEA, Control Plans, Acceptance criteria, Sampling Plans.
- Strong technical aptitude and experience (preferably in engineering, chemistry, biology or other life sciences field) is a must.
- Quality Tools – Problem Solving Methodologies/Process Capability / ISO 13485 / Design of Experiments.
- Ability to communicate effectively with all levels of employees throughout the organization
- Ability to develop and maintain strong working relationships with internal and external customers
- proficient in Microsoft Office, statistical software programs, operating systems, voice and email, etc.
- Ability to lead and facilitate a group of technical experts in root cause investigations
- Knowledge of quality systems and regulations for medical device industry.
- High level of technical writing ability and excellent communication skills are required
- Advanced skills in statistical techniques and quality tools is required
- Understanding of medical device Quality System Regulations (QSR) is required
Before you apply, please make sure you share Quidel’ s values. We pride ourselves on keeping these values in mind every day as we execute on goals and plan for the future. We are seeking employees who share the same mindset and commitment to be
customer driven,
focused on execution, and
new product oriented. We succeed by being
determined,
optimistic team players.
Quidel is proud to be an Affirmative Action/Equal Opportunity Employer (Minorities/Women/Disabled/Veterans). We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
johnandkristie.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, johnandkristie.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, johnandkristie.com is the ideal place to find your next job.