Santa Monica Classifieds > Jobs > Technology

pPartial Job Descriptionp p1 Manage the design, specification and installation of new and renovated biopharmaceutical process equipmentp p2 Provide engineering and issue solving support for existing equipment and manufacturing processesp p3 Design and specify cGMP process equipment, piping and controlsp p4 Manage small projects related to process equipment and manufacturingp p5 Manage the desig...

pPartial Job Descriptionp p1 Manage people, multiple product lines and teamsp p2 Plan, motivate and direct Clinical Engineering group to drive the overall strategic initiativesp p3 Develop, lead, coach and build Clinical Engineering teamp p4 Establish and follow consistent process and metric to effectively measure and improve team performancep p5 Monitor overall clinical engineering project sta...

pPartial Job Descriptionp p1 Ensure developing, fabricating and evaluating processes in the plant to develop equipment, fixturing and tooling for production of highly precise, delicate and expensive medical device components used for minimally invasive surgery productsp p2 Develop a blue print and take each product from design to fruitionp p3 Ensure reading, calibrating, training and utilizing ...

lines and procedures for validation and calibrationp p2 Develop Validation Master Plans and Validation Project Plans to ensure that all validation tasks required to support both operational areas and corporate projects are identified and completed within established time framesp p3 Design, prepare, execute and statistically analyze Installation Requirements IQs, Operational Requirements OQs, Pe...

nd ensure the design process meets all requirementsp p3 Review design drawings for tolerance, inspect-expertise and quality of design issuesp p4 Work with suppliers to improve quality and assist, where necessary, in supplier process validationsp p5 Train andor assist QC Manager in the training of QC Inspectors on inspection techniques and the use of new equipmentp p6 Participate in internal and...

1 Formulate drug product process development, both oral and sterile and scale-up, packaging, technology transfer, cGMPs, ICH guidelines as well as CMC content of regulatory submissions two Ensure CMC writing for regulatory submissions, INDNDA, process development reports, process validation protocol and other supporting technical documents three Ensure CMC gap analysis and identification of cri...

ams as a Project Manager four Oversee project managers within the biotechnology product line five Develop insight into customer qualifications and markets in order to provide suggestions for product additions and applications to expand current markets and develop new markets six Work in synergy with other departments to meet sales and profit goals seven Work in cooperation with the Director of ...

unications and activities to adequately respond to agency inquiries and requests four Represent Regulatory Affairs on assigned project teams through all phases of product development five Communicate regulatory qualifications and the impact of regulations to the development team to ensure compliance for product development, labeling andor promotional issues six Review changes in products, produ...

Partial Job overview one Design and build user interfaces for the CDR two Be involved in other phases of the product life-cycle such as reviewing functional specifications, development of proof-of-concept prototypes and code development of other application components. three Support requests made by Director of QA in response to client auditsbr More questions Want to know the Compensation range...

Partial Position details one Provide support to the head of the Quality Assurance and Regulatory Compliance departments, by proposing and implementing process improvements and maintaining and improving various quality system processes two Monitor and improve existing QMS processes to streamline and ensure compliance as well as generate relevant metrics for these processes and reports to managem...

Partial Job overview 1 Investigate, plan and implement improvements in andor additions to current products and manufacturing processes that directly affect safety, quality and productivity with the end-result of producing a better quality product more efficiently two Ensure compliance to the companys quality policy, respond to customer complaints, perform audits, develop test methods andor writ...

the selection of CMO and oversight of ongoing CMO activities. Selection assignments include certification that the facility, procedures, equipment, personnel and processes can consistently deliver product that meets company qualifications, while oversight assignments include review of batch documentation, deviations, investigations, etc. up to and including product release. four Ensure maintena...

tify critical component features and supplier manufacturing processes five Develop and validate supplier manufacturing processes six Implement appropriate process controls and monitoring seven Conduct gage repeatability and reproducibility, measurement system correlation and process capability studies eight Assist suppliers with the development and implementation of statistical sampling plans a...

engineering team operating in a matrix organization that researches, designs, develops, and tests electrical components, equipment, systems, and products for the medical device industrybr More questions Want to know the Compensation range Keep reading. br br The best way to get more info is to click Apply, upload your resume, and ENTER YOUR QUESTIONS in the Introductory letter field. A recruite...

Partial Job details one This position provides QA oversight to Product Development and Technical Services processing, laboratory analysis and release of products to clinic. two The Manager Quality Assurance RD supports the compliant and timely closure of all project work requiring Quality Assurance approval. three The Manager Quality Assurance RD reports to the Director Quality RD and supports ...

Partial Position description one Provide the leadership, strategic insight, direction, and implementation for all quality assurance activities resulting in continued product improvement and compliance two Provide the leadership, strategic insight, direction, and implementation for all quality assurance activities related to new product development, product improvement, and compliance three Staf...

Partial Position details one Plans, directs, and coordinates QA program activities at all company locations. two Selects, trains, and supervises staff to perform quality assurance functions consistent with strategic plans for ongoing implementation of the company Quality Policy. three Determines staffing levels needed to meet objectives and assist in formulation of strategic initiatives based o...

Partial Position details one Responsible for the design, implementation and management of design development programs, from concept through product release in an ISO 134852003 and FDA QSR environment. This will include training the appropriate personnel on company design development processes and procedures. two Assist in creating design development program quality plans, including program phas...

Partial Position details one Manage all regulatory and quality activities for the company two Develop, implement and evaluate effective processes that are consistently adhered to three Develop, implement and maintain quality system policies and procedures of the company four Develop staff competencies to achieve a world-class regulatory compliance culture 5 Ensure budgets, schedules, staffing, ...

and nuclei acid purification and characterization, reaction kinetics, conjugation chemistries, and design, validation and transfer to manufacturing of new controls, test methods and assay components four Collaborate with technical and marketing personnel and other internal and external resources regarding product design 5 Lead a team of project managers to manage a changing array of projects in...