Quality Engineer - P3

Boston Scientific; Cork; On-site; EUR 45,000 - 60,000; Full time

Job summary

A leading medical device company in Cork is looking for a Quality Engineer to ensure compliance with quality standards and improve processes. The role entails problem-solving within manufacturing, providing technical guidance, and driving quality improvements. Candidates should hold a relevant engineering/science degree and have over 4 years of experience in a manufacturing environment. Strong communication and analytical skills are essential. This is a permanent onsite position.

Qualifications

• Minimum of 4+ years’ experience within a manufacturing environment.
• Excellent interpersonal and communication skills.
• Strong knowledge of quality principles.

Responsibilities

• Identifies and resolves complex exceptions to work assignments.
• Checks and provides support in execution of CAPAs.
• Gives technical guidance to Quality Technicians.

Skills

Interpersonal skills

Analytical skills

Problem-solving skills

Teamwork

Decision making

Education

Level 8 qualification in Engineering / Science

Tools

Six Sigma

Statistical Analysis

Job description

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

Role: Permanent, onsite
Closing Date: October 20th

Purpose Statement
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.

Key Responsibilities

• 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.
• 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.
• Knowledgeable of standards, constantly promoting awareness of best industry practices, making appropriate decision daily
• Fully conversant with validation techniques and associated regulatory requirements
• Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities
• Knowledgeable on Risk Management.
• Compiles and analyses operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
• Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.
• Gives technical guidance to Quality Technicians and Quality Engineer
• 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.

Education & Experience

• 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 4+ 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.

We are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.

Boston Scientific is an Equal Opportunity Employer and welcomes applications from diverse candidates.