MAnager, Technical Operations
- Job Title
- MAnager, Technical Operations
- Job ID
- 27682674
- Location
- Garden Grove, CA
- Other Location
- Description
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Hycor is seeking a highly motivated, dynamic individual for this exciting opportunity to lead its Technical Operations Department.
We are seeking driven, ambitious candidates with excellent critical thinking and technical skills.
Reporting to the CSO, the right candidate will provide operational and customer support through investigations, troubleshooting, and root cause analysis.
A background in biology, chemistry, or related discipline is required. Experience in diagnostic product development and/or manufacturing desired.
Principal Job Duties and Responsibilities
- Manage and lead a cross-functional team in order to implement process/product improvements, product troubleshooting, complaint investigations, and design transfer.
- Oversee and ensure Technical Operations laboratory is operating per the QSR’s, and Hycor’s Quality Management System, and appropriate safety work instructions.
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Actively manage personnel to enhance morale and employee advancement. This includes discipline as necessary, cross-training efforts, employee recognition, etc.
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Develop workforce through supervision, coaching, and training.
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Write and deliver annual personal performance goals in support of higher level business plans/objectives.
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Effectively develop and manage budget.
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Monitor current and projected workloads to determine staff requirements.
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Effectively implement corrections/corrective actions/preventive actions to known/potential nonconformities, as part of the CAPA process.
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Represent Technical Operations at selected meetings as requested.
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Support company policies and procedures, goals and objectives, FDA/ISO regulations, and Good Manufacturing practices.
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Interact frequently with quality, purchasing, inventory control, production control and R&D.
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Interact with all co-workers and management in a positive, supportive and cooperative way.
Training and Education: B.S. degree in biological sciences, Clinical Lab Scientist or equivalent. At least 5-7 years’ experience in related managerial function and practical knowledge of Immunoassay concepts and Clinical Laboratory automation and instrumentation; Preference for Master’s degree.
Experience: A minimum of 5 years’ experience in a customer facing or similar management role. The applicant should be familiar with IVD medical devices and concepts, practices, procedures, rules and regulations. Technical experience with medical device systems (hardware and software) also preferred. Experience developing Standard Operating Procedures that follow FDA regulations for complaint handling and documentation.
Skills: The applicant must be highly skilled at communication, both written and verbal, and must be able to interact with people of all scientific levels, such as clinical laboratory technicians, safety officers, managers, supervisors and directors; CLIA, CAP and FDA regulators and inspectors; key opinion leaders (KOL); clinical product managers; researchers; hospital administrators; medical engineers; and physicians. The Applicant should have strong leadership and organizational skills. Ability to interact with our customers on a level that inspires confidence and secures customer loyalty. Project Management skills as well as the ability to organize and present data to large groups.
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HYCOR is committed to hiring and retaining a diverse workforce. We are proud to be an Equal Opportunity Employer, making decisions without regard to race, color, religion, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected class.