The Supplier Quality Engineer is responsible for completing Supplier Quality Assurance activities within Beckman Coulter Ireland ensuring Quality system regulations are complied with.
Responsibilities
Support new supplier/material introductions to ensure that all requirements under the Beckman Coulter Supplier Qualification process are maintained
Supplier liaison and evaluation – including participation in the Supplier Selection Process and review of supplier supplied information via self-assessments, SQA etc
Facilitate root cause analysis and corrective actions of supplier quality issues through the NC/SCAR processes
Manage Supplier Change Notifications
Participate in cross-functional teams in the development of new products or changes related to current products
Requirements
BSc in chemistry, biochemistry, engineering or other relevant technical field
Lead and manage quality functions for manufacturing operations, ensuring compliance with industry standards and continuous improvement.
Compensation
Expected salary: $120,000 - $145,000 annually.
Responsibilities
Establish a quality system continuous improvement program
Manage challenging customer quality requirements such as PPAP
Own the problem-solving process for quality and drive usage through quality team
Drive quality direction for new product development and commercialization
Establish and maintain critical-to-quality specifications, test plans, procedures, tools, and meaningful metrics to control all aspects of manufacturing
Requirements
Bachelor's degree in engineering, manufacturing or related field
Senior Manufacturing Engineer responsible for designing, developing, and validating manufacturing processes for medical device products in the Abbott Vascular Devices division.
Compensation
$78,000.00 – $156,000.00
Responsibilities
Design and develop manufacturing processes for life sciences products
Develop procedures for economical mass production in cooperation with pilot-plant and production departments
Conduct tests and measurements throughout production stages
Troubleshoot and solve production process problems
Lead equipment and manufacturing process qualification activities (IQ, OQ, PQ)
Leads multiple or moderately complex projects independently, managing cross-functional initiatives with moderate risk or technical complexity.
Compensation
The estimated salary range for this role is between $92,100-$138,200. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux’s bonus program.
Responsibilities
Develop and manage integrated & comprehensive project plans and schedules
Manage scope, risk, budget, and stakeholder expectations
Communicate clearly across functional and external teams
Ensure compliance with internal and regulatory frameworks
Analyze metrics and use data for decision-making
Requirements
Bachelor’s degree: Engineering, Technology, Life Sciences, Business, Project Management
Oversee sterilization processes within medical devices and provide technical support related to sterilization across all certification schemes - MDR, MDD, UK MDR, ISO13485, MDSAP, IVDR.
Responsibilities
Oversee sterilization processes within medical devices and provide technical support related to sterilization across all certification schemes - MDR, MDD, UK MDR, ISO13485, MDSAP, IVDR.
Act as line manager and lead the team of MDR Product Assessors-Sterilization.
Provide technical advice in relation to sterilization to support all stages of the medical device conformity assessment process.
Establish competence criteria, update, deliver and maintain appropriate training packages for Product Assessors (sterilization team) as well as sterilization auditors covering all certification schemes related to sterilization within the medical device conformity assessment process.
Develop, maintain and implement sterilization QMS documentation related to medical devices conformity assessment process of SGS NB 1639 aligned with best practices (e.g. NBOG’s BPG, MDCG guidance documents) and applicable regulatory and accreditation requirements.
Requirements
University or a technical college degree or equivalent qualifications in relevant studies, such as microbiology
Under minimal supervision, responsible for independently setting basic quality standards for both in-process while leading efforts to develop methods for testing, sampling and training.
Compensation
The anticipated salary range for this position: $101,000.00 - $152,000.00 Annual
Responsibilities
Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure that products are ideal and functional.
Design complex experiments to understand sources of variation affecting products and processes.
Apply statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
Design and perform experimental product testing and analysis to maintain quality levels and minimize defects and failure rates.
Generate and analyze reports and defective products to determine trends and lead corrective actions.
Requirements
Bachelor’s degree in Engineering, Science, Math or other related technical field
As a key member of the Foot & Ankle Quality NPI team, you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.
Compensation
Base Pay Range: $86,520 - $94,760 - $104,174 (reflective of a full-time position) Employees in this position are also eligible to earn an annual performance bonus.
Responsibilities
Participating in design and manufacturing reviews
Generating DFMEAs/UFMEAs and participating in risk analysis discussions
Develop inspection strategy and methods to support the development and launch of new products
Reviewing and approving design and development documentation
Serve as subject matter expert for design quality in ISO and FDA audits
Requirements
Bachelor’s degree in Biomedical or Mechanical Engineering
Financial & Career Growth – Life insurance, short-term disability, educational reimbursement, flexible spending accounts, and an employee stock purchase plan
401(k) Matching – 100% match at a 6% contribution level
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