Quality Engineer III
Boston Scientific
- Cork
- Permanent
- Full-time
- Location: Cork
- Req Number: 580936
- Contract type: Permanent
- 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. May be respons
- 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.
- Document investigation findings in analysis report on GCS2
- Become a trainer for the Software related with complaints handling process (GCS2), as required.
- 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.
- 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 deci
- Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints.
- 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 , BSEN 14971 requirements.
- Compiles and analyses operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
- 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.
- Assure that all laboratory equipment is in compliance to perform the analysis activities (calibration, safety, cleanliness).
- 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.
- Deals with suppliers, other engineering disciplines within and outside of the Site and customers should the need arise.
- Is familiar with the internal auditing process.
- Requires a minimum level 8 qualification in a relevant Engineering / Science degree.
- Excellent interpersonal and communication skills.
- Ability to work as part of a team and meet targets/goals efficiently.
- Excellent analytical and problem-solving skills.
- Demonstrated decision making skills.
- Minimum of 3+ years’ experience within a manufacturing environment.
- People management experience is advantageous.
- Strong knowledge of quality principles and the ability to utilize these methods in a manufacturing environment.