Senior Sterility Assurance Microbiologist
hace 7 meses
Work Shift:
DAY
Work Schedule:
Why Merit?
At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.
ESSENTIAL FUNCTIONS PERFORMED
1. Supports New Product Development, Acquisition and Operations Engineering teams creating and implementing plans for sterility assurance activities to support new/modified products/processes for the assigned region/site.
2. Communicates and interfaces with contract sterilizers, laboratories, and internal customers (R&D, Operations, Regulatory Affairs and Sterility Assurance) as required to effectively manage effectively manage day to day processing requirements.
3. Performs and documents product qualifications into existing EO sterilization cycles using the appropriate standards development/modification of sterilization processes for new or existing products.
4. Performs and documents product adoptions into existing EO cycles, including selection and justification of master product.
5. Develop, review and approve sterilization process qualifications and routine dose audits.
6. Develop, qualify and implement microbiological test methods to support sterility assurance of products.
7. Review sterilization and laboratory documentation to ensure compliance with procedures.
9. Support cleanroom and installation and qualification activities including protocol development, review and/or approval.
10. Provide environmental monitoring inputs, conduct and/or manage testing (contract testing laboratories), analyze data and write test reports as applicable.
11. Review sterilization and environmental documentation to ensure compliance with procedures and applicable regulations.
14. Lead or participate in sterility assurance technical audits for Merit manufacturing sites and for contracted services.
15. Keep abreast of current technologies and regulatory standards.
16. Align to and drive for global standardization and harmonization specific to the policies, procedures and working instructions that produce product sterility assurance and regulatory compliance.
17. Drives ongoing sterilization programs and projects for Merit harmonizing, where possible, the quality systems and processes used throughout Merit. All changes to the Merit sterilization program should align within Merit corporate quality goals, while maximizing Merit productivity and maintaining a high level of regulatory compliance.
18. Actively coordinate, train and develop a staff of sterility assurance professionals dedicated to ensuring the product release, change control, validation/adoptions, contract management, experimentation and all associated activities deliver customer satisfaction through product quality, process efficiency, sterility assurance and national and international regulatory compliance.
19. Keep self, staff and company current on ANSI, AAMI, ISO, USP, EPA and all other national and international standards that ensure product sterility assurance, employee safety and regulatory compliance.
20. Performs a variety of other related tasks, as required.
ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS
- Lifting - Not to exceed 50 lbs. - local practice may apply.
- Writing
- Sitting
- Standing
- Bending
- Visual acuity
- Color perception
- Depth perception
- Reading
- Field of vision/peripheral
- Fine motor skills
SUMMARY OF MINIMUM QUALIFICATIONS
- Degree in Quality Engineering/Engineering/Science, or equivalent qualification essential (NFQ Level 7, or higher).
- A minimum of 7 years relevant experience within a medical device/pharmaceutical manufacturing facility, with at least 5 years having performed activities associated with sterilization and control of microbial contamination of products and processes, coupled with a proven track in leading functional area through regulatory inspections.
- In depth knowledge and experience of sterilization technologies, and their associated guidance standards (11135, 11137, 17665, etc.).
- Applied knowledge in ethylene oxide, irradiation &/or steam sterilization modes, including validation at a minimum; knowledge in other sterilization techniques such as aseptic filling most desirable.
- Applied knowledge of microbiological labs, controlled environments, and sterile barriers.
- Working knowledge of and experience with U.S. FDA regulations, the Medical Devices Directive (93/42/EEC & MDR EU 2017/745), Invitro Diagnostic Medical Device Directive (93/79/EC & MDR EU 2017/746), ISO 13485 Quality System Standard, ISO 14971 Risk Management, Canadian Medical Device Regulation (CMDR), and JPAL/JGMP as they pertain to Sterility Assurance.
- PC skills including standard offices packages as well as ability to understand and learn customized computer software programs.
PREFERRED QUALIFICATIONS
- Degree in Microbiology.
- Master’s degree.
- Demo
-
Sterility Assurance Specialist
hace 4 semanas
Tijuana, México Avent, S. de R.L. de C.V. A tiempo completoDescripción y detalle de las actividades 1. Support the implementation of Global Sterility Assurance Quality Operation program at the Avanos manufacturing sites. 3. Coordinate activities with the contract sterilizers and contract laboratories to support execution of sterilization validation / revalidations. 4. Analyze sterilization reports in accordance...
-
Sterility Assurance Specialist
hace 4 semanas
Tijuana, Baja California, México Avent, S. De R.L. De C.V. A tiempo completoAvent, S. De R.L. De C.V. seeks a highly skilled Sterility Assurance Specialist to join our team in Quality Assurance. As a key member of our quality team, you will be responsible for supporting the implementation of our Global Sterility Assurance Quality Operation program at our manufacturing sites.The successful candidate will have a B.S in Microbiology,...
-
Sterility Assurance Expert for Medical Devices
hace 2 meses
Tijuana, Baja California, México Merit Medical Systems Inc. A tiempo completoJob SummaryWe are seeking a highly skilled Sterility Assurance Expert for Medical Devices to join our team at Merit Medical Systems Inc.This is a challenging and rewarding role that requires expertise in sterilization technologies, microbiological testing, and regulatory compliance. As a Sterility Assurance Expert, you will play a critical role in ensuring...
-
Tijuana, Baja California, México Medtronic A tiempo completoAbout the RoleWe are seeking a highly skilled Senior Microbiologist to join our team in Microbiology and Sterility Assurance. This is a challenging and rewarding opportunity to contribute to the development of sterilization and analytical services that improve patient outcomes.Key ResponsibilitiesAnalyze chemical, biological, or microbiological products, raw...
-
Sr Microbiologist-steriliz
hace 2 semanas
Tijuana, México Medtronic A tiempo completo**Careers that Change Lives **A Day in the Life Responsibilities may include the following and other duties may be assigned. - Work independently with guidance and direction from senior members of the team and manager. - Assure all quality requirements are in compliance with regulations and product specifications. - Provide understanding of the audit process...
-
Senior Quality Assurance Specialist
hace 2 meses
Tijuana, Baja California, México Sensata Technologies A tiempo completoJob SummaryWe are seeking a Senior Quality Assurance Specialist to join our team at Sensata Technologies.
-
Senior Quality Assurance Specialist
hace 1 mes
Tijuana, Baja California, México Domo Industrial A tiempo completoAbout the RoleWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Domo Industrial.
-
Microbiologist-steriliz I
hace 2 semanas
Tijuana, México Medtronic A tiempo completo**Careers that Change Lives **A Day in the Life Responsibilities may include the following and other duties may be assigned. - Work in collaboration, guidance and direction from senior members of the team and manager. - Assure all quality requirements are in compliance with regulations and product specifications. - Perform, coordinate, execute and summarize...
-
Senior Quality Assurance Manager
hace 4 días
Tijuana, Baja California, México Buscojobs México A tiempo completoAbout the RoleAre you a seasoned professional looking to take on a leadership role in Quality Assurance? We are seeking a highly skilled Senior Quality Assurance Manager to join our team at Buscojobs México. In this position, you will be responsible for overseeing the quality assurance processes and ensuring that our products meet the highest standards of...
-
Senior Quality Assurance Strategic Lead
hace 2 semanas
Tijuana, Baja California, México Fine Talent A tiempo completoJob OverviewFine Talent is seeking a Senior Quality Assurance Strategic Lead to oversee quality and regulatory compliance for multisite manufacturing operations in Mexico.ResponsibilitiesProvide visionary leadership to quality assurance teams across multiple sites, fostering a culture of accountability, innovation, and excellence.Develop and execute a...
-
Senior Quality Assurance Specialist
hace 2 meses
Tijuana, Baja California, México Medtronic A tiempo completoAbout the RoleWe are seeking a skilled Senior Quality Assurance Specialist to join our team. As a key member of our quality engineering team, you will be responsible for developing and implementing quality standards and protocols for processing materials into partially finished or finished products.ResponsibilitiesDevelop, modify, apply, and maintain quality...
-
Microbiology Laboratory Technician
hace 5 días
Tijuana, México Stryker A tiempo completoJob Summary The Lab Technician I is responsible for execution and recording of results for all laboratory testing. This position will support all sterility assurance, product quality, & endpoint testing for operational support and release. In addition, the Lab Technician I will support all activities to sustain required testing and monitoring, this to...
-
Microbiology Laboratory Technician
hace 15 horas
Tijuana, México Stryker A tiempo completoJob Summary The Lab Technician I is responsible for execution and recording of results for all laboratory testing. This position will support all sterility assurance, product quality, & endpoint testing for operational support and release. In addition, the Lab Technician I will support all activities to sustain required testing and monitoring, this to...
-
Senior Quality Assurance Manager
hace 2 meses
Tijuana, Baja California, México Integer A tiempo completoJob Description:We are seeking a highly skilled Senior Quality Assurance Manager to join our team at Integer.Key Responsibilities:Supervise a group of 5 Inspectors and 1 QC Technician for In-process and Final QC Inspection.Meet goals and objectives for 2024 QA KPI'sNon-conformance investigations and product evaluation/disposition.Customer complaint...
-
Senior Quality Assurance Specialist
hace 2 meses
Tijuana, Baja California, México Enovis A tiempo completoCompetitive Salary: $85,000 - $110,000 per yearAbout EnovisWe are an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows.Job OverviewAs a Senior Quality Assurance Specialist at Enovis, you will be accountable for implementing...
-
Senior Quality Assurance Director
hace 2 semanas
Tijuana, Baja California, México Chromalloy Gas Turbine LLC A tiempo completoChromalloy Gas Turbine LLC is a leading global provider of aftermarket parts, repairs, and solutions for the aerospace, energy, and defense industries. We are seeking an experienced Senior Quality Assurance Director to lead our quality function and drive performance.About the RoleThis is a unique opportunity to join a dynamic organization and contribute to...
-
Microbiologist Specialist
hace 7 días
Tijuana, Baja California, México Medtronic A tiempo completoAbout the RoleWe are seeking a highly skilled Microbiologist Specialist to join our team. In this role, you will be responsible for ensuring all quality requirements are met in compliance with regulations and product specifications.ResponsibilitiesSome of the key responsibilities of this role include:Working independently with guidance from senior members of...
-
Microbiology Laboratory Technician
hace 7 meses
Tijuana, México Stryker Corporation A tiempo completo**1. Job Summary** This position requires knowledge that is acquired through experience, specialized education or training. The role has clearly defined procedures and tasks as well as defined guidelines to aid in decision making. The job requires a basic understanding of work routines and procedures in own discipline. The technical procedures for this...
-
Senior Quality Assurance Engineer
hace 4 semanas
Tijuana, Baja California, México North American Production Sharing A tiempo completoAbout the Role:North American Production Sharing is seeking an experienced Senior Quality Assurance Engineer to join our team. This full-time position offers a competitive salary of $85,000 per year.Job Summary:The Senior Quality Assurance Engineer will be responsible for ensuring that all manufactured products meet quality standards and regulations. Key...
-
Senior Quality Assurance Manager
hace 4 días
Tijuana, Baja California, México Smk Electrónica A tiempo completoOverviewSmk Electrónica seeks a skilled Senior Quality Assurance Manager to lead our electronics division's quality efforts. In this role, you will be responsible for ensuring the highest standards of quality in all aspects of our operations.Job SummaryWe are looking for a seasoned professional with expertise in quality assurance, particularly in the...
