Staff Manufacturing Engineer

Reposted Yesterday
San Juan Capistrano, CA, USA
In-Office
141K-216K Annually
Senior level
Healthtech • Database
The Role
Manage manufacturing engineering activities for in-vitro diagnostics, ensuring compliance with regulations, improving processes and leading product development activities.
Summary Generated by Built In

Quest Diagnostics Inc. in San Juan Capistrano, CA seeks Staff Manufacturing Engineer (multiple positions) to, as part of the Pharma Services Team, manage all activities associated with manufacturing engineering and shared services in support of all in-vitro diagnostics products manufactured at Quest. Provide oversight of engineering activities associated with equipment and process validations, improvement projects, packaging designs, technology transfers, and shared services. Lead product development activities in collaboration with Manufacturing and R&D. Design manufacturing processes to improve efficiency, productivity, and quality. Ensure manufacturing processes follow IVDD/IVDR, FDA, and ISO requirements. Supervise team of 1-5 employees. Up to 25% domestic travel required to east coast facilities/offices. 

 

REQUIREMENTS: Bachelor’s degree (or foreign equivalent) in Engineering (any) or related technical field. Experience must include: 5 years of experience in Manufacturing or Engineering within in-vitro diagnostics (IVD), medical devices, or pharmaceutical industry; IVD manufacturing technologies (reagents/kitting) processes, and systems; ensuring compliance with FDA and ISO requirements for facility services; 3 years of experience in equipment controls and equipment selection and purchasing (bottling, liquid dispense, labeling, printing); and utilizing Lean or SixSigma principles and methodologies for improvement projects.

 

Salary range $140,774 - $215,700 / year 


To apply, submit CV on careers.questdiagnostics.com using requisition number: 57652

About the Team Quest Diagnostics honors our service members and encourages veterans to apply.
While we appreciate and value our staffing partners, we do not accept unsolicited resumes from agencies. Quest will not be responsible for paying agency fees for any individual as to whom an agency has sent an unsolicited resume.
Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets or any other legally protected status.
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The Company
HQ: Secaucus, NJ
25,839 Employees
Year Founded: 1967

What We Do

Quest Diagnostics (NYSE: DGX) empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our 47,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. The company offers physicians the broadest test menu (3,000+ tests), is a pioneer in developing innovative new tests, is the leader in cancer diagnostics, provides anatomic pathology (AP) services, & interpretive consultation through its medical & scientific staff of about 900 M.D.s & Ph.D.s. The company reported 2020 revenues of $9.44 billion. Quest Diagnostics offers the most extensive clinical testing network in the U.S., with laboratories in most major metropolitan areas, & in Mexico, the UK & India. The company also operates four esoteric laboratories, 40 outpatient AP laboratories, & 160 smaller, rapid-response laboratories. Patients may have specimens collected in any of the company’s approximately 2,250 patient service centers. On a typical workday, testing is performed for about 550,000 patients. Quest Diagnostics empowers healthcare organizations & clinicians with state-of-the-art connectivity solutions. The company is the leading provider of pre-employment drugs-of-abuse screening for employers & risk assessment services for the life insurance industry. It is the world’s 2nd largest provider of clinical trials testing for new pharmaceuticals. More information is available at www.questdiagnostics.com. Language Assistance / Non-Discrimination Notice Asistencia de Idiomas / Aviso de no Discriminación 語言協助 / 不歧視通知 www.QuestDiagnostics.com/home/nondiscrimination

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