Senior QA Engineer Diagnostic Hybrids
THIS JOB HAS EXPIRED Category: Engineering
Come join our team! Exciting things are happening at Quidel and you can be part of our growth. The Senior Quality Assurance Engineer will be responsible for supporting new product design/development activities utilizing internal and external quality derived industry standards. The incumbent may also lead corrective action/preventive action projects. Additional responsibilities include: ? Administering Master Validation Plans (MVP). ? Execute FMEA?s (Design, process and User). ? Develop new product design trees. ? Generate Engineering 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. ? Provide direction and training to team members for FMEA?s 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.
Education and experience:
BA/BS in Scientific field required, QE certified desired. ? 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.
? 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, FMEA?s, QTP?s and Master validation plans). ? Knowledge of related quality systems regulations and processes. ? Appropriate computer skills (e-mail, word processing, statistical, spreadsheet and graphing software)
Quidel is proud to be an Equal Opportunity/Affirmative Action Employer (M/F/D/V).
Location San Diego , CA
Minimum Experience (yrs):
Required Education: Not Specified
||San Diego, CA |
THIS JOB HAS EXPIRED