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Costa Rica-Heredia
About the role:
Evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications. Assignments have clear and specified objectives and require the investigation of a limited number of variables. Improve existing manufacturing processes and act as liaison between production and engineering group in resolving problems encountered on the production floor. Assist with the introduction of new products into the Operations production area.
Your Responsibilities Include:
What we're looking for:
Benefits • Life-Work Integration • Community • Career Growth
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工作职责:
岗位要求:
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Hybrid Roles:
About the Role:
Provide oversight of Microbiology Department for the sustaining operation, support projects requiring microbiology evaluation or testing. Under the direction of the Microbiology Manager, this position will serve as senior matter expert on microbiology, assuring the product meets documented requirements and that processes are controlled and providing support and guidance in the areas of cGMP, Regulatory, technical investigations.
Your Responsibilities Include:
· Strong knowledge of microbiology test methods, standards and regulations governing the quality system and microbiological topics.
· Review and assess from a microbiology context all changes that impact product or the cleanroom environment.
· Support new product development by participating as the microbiology functional team member and represent the Microbiology department on cross-functional project teams as required.
· Support Regulatory submissions by conducting review to ensure appropriate microbiology information is present in the submission.
· Review test reports from internal, external testing for compliance to BSC and external compliance requirements.
· Ensures that products are validated for bioburden and endotoxin testing and support the establishment of routine sampling plans.
· Support Internal/External Audits and ensures all non-conformances are adhered to in a timely manner.
· Provide technical guidance/troubleshooting in the event of Microbiology related issues.
· Act as Quality Engineer for Facilities related matters.
· Revise SOPs and support maintenance of product and environmental documentation.
· Support product bioburden alert limits and cleanroom air and surface alert and action limits periodical revision.
· Organizes and presents data/ information to influence decision making, primarily to internal audiences
What We’re Looking For:
• Degree in Microbiology, Biotecnology or related field.
• At least 3 years of experience in similar position.
• English Level desired: 80-89%.
Benefits • Life-Work Integration • Community • Career Growth
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Our Graduate Programme is designed to accelerate your professional development and provide you with extensive experience within Boston Scientific Clonmel. Throughout the 23 month programme, you will be provided with dedicated mentors and will have professional development 1:1 meetings to provide you with a solid foundation for a successful career. Our Graduate Programme is created around hiring the most innovative and best individuals, while Boston Scientific Clonmel provides the means for you to continuously learn and enhance your skill set to drive your career growth.
Responsibilities
Required
** 23 Month Contract ** Closing Date 27th November
Should you require a reasonable accommodation during the recruitment process or after if offered, please let us know.
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About the role:
Demonstrates commitment to the Quality Policy (patient safety and product quality) through their daily execution of sound quality practices and the maintenance of an effective quality system. Understands and complies with all the regulations governing the quality systems. Ensures their direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.
You're Responsibilities include:
Lead Products & Processes Transfers from a Quality standpoint.
Identifies and resolves complex exceptions to work assignments.
Summarizes, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings.
Read and interpret technical drawings, procedures, and protocols
Identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions.
Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
Participates in Customer Complaints investigation for areas under their control.
Continually seeks to drive improvements in product and process quality.
Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
Evaluates new equipment and processes and participates in the transfer of new products.
Understanding of product quality plans, documents and systems by reviewing product specifications, quality specifications, and working with quality systems. May be responsible for learning risk analyses and FMEAs.
Knowledgeable on QSR and ISO/MDD standards, constantly promoting awareness of best industry practices, making appropriate decision on a daily basis utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decisions.
Get involve in various stages of equipment and processes validations: Run and/or review and approve reports: TMVs, I.Q 's, O.Q's and P.Q's as well as any other document relating to validation.
Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints.
Compiles and analyses operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities.
Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
Knowledgeable on Risk Management, ISO EN 14971 requirements.
May participate directly in a new product/technology transfer to ensure compliance to all internal and regulatory requirements.
Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.
Gives technical guidance to Associate Quality Engineer, Technician and Inspection staff.
Is a good team member, fully motivated to achieve and demonstrate best practices in line with the department and Site objectives.
Is familiar with the internal auditing process.
What We’re Looking For:
Bachelor's degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or Related Field.
English Level desired: B2 (80-89%)
Experience: proven experience in Medical or Pharmaceutical industry, working on Quality, Process Development or Engineering Department. Solid knowledge in Statistics, Problem Solving techniques, Quality System, Process and Test Method Validation, Risk Management, Six Sigma or similar.
Desired knowledge: Product and Process Transfer and Project Management. ASQ certified desired.
At least 3 years of proven experience in similar position.
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Costa Rica-Heredia
Your Responsibilities Include:
What We’re Looking For:
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Costa Rica-Heredia
Hybrid Roles:
About the role:
To develop, implement, and ensure continuous improvement of the Environment, Health and Safety (EH&S) systems. The primary purposes of these systems are: 1) maintaining compliance with the requirements of Boston Scientifics’ corporate EH&S policies and requirements and all applicable national, state, and local regulations, 2) driving EH&S performance improvements across the site, and 3) capturing and communicating information describing EH&S roles, responsibilities and contribution. 4) Lead the direct reports under him/her. This position will report directly to the EH&S Supervisor
Your Responsibilities Include:
What We’re Looking For:
Benefits • Life-Work Integration • Community • Career Growth
These jobs might be a good fit

Costa Rica-Heredia
About the role:
Evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications. Assignments have clear and specified objectives and require the investigation of a limited number of variables. Improve existing manufacturing processes and act as liaison between production and engineering group in resolving problems encountered on the production floor. Assist with the introduction of new products into the Operations production area.
Your Responsibilities Include:
What we're looking for:
Benefits • Life-Work Integration • Community • Career Growth
These jobs might be a good fit