Project Quality Engineer at Boston Scientific Corporation Malaysia

Kerkrade, Limburg, Netherlands -

Full Time

Start Date

Immediate

Expiry Date

16 Mar, 26

Salary

0.0

Posted On

16 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Standards, Process Validation, Risk Management, Statistical Analysis, Problem Solving, Documentation Skills, Cross Functional Communication, Change Control, Process Characterization, GMP/GDP Environment, Medical Device Industry, ISO 13485, ISO 14971, CAPA, FMEA, SOPs

Industry

Medical Equipment Manufacturing

Description

Actively participates as a quality core team member in a strategic site project. Pro-actively implements Quality standards, principles and procedures in the operational processes to ensure that processes are executed per Corporate and Regulatory requirements. Understanding of process validation life cycle, incl. process characterization, IQ, OQ and PQ. Support Process Validation activities as required per the project requirements, incl. support in developing, reviewing and release of validation documentation such as validation plans, protocols and reports. Participate in process risk analysis. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues (CAPA, Is/Is not problem statement, Fishbone diagram, Pareto, FMEA). Effective cross functional communication with operations, logistics, engineering, and quality assurance teams. Understands and applies quality principles to support an effective overall quality management system. Supports change control activities. Supports in the development and review of process related documentation (SOPs, Work Instructions). Flexibility to perform general QA related activities. Prioritization of patient impact during decision making, risk assessments, and change control. 3+ years experience in a GMP/GDP environment with Bachelor's Degree or equivalent. Prior experience in the medical device industry is preferred. Comprehensive understanding of the EU MDR, ISO 13485 and ISO 14971 standards Experience in process validation is required Proficiency in statistical analysis, sampling strategies, and process capability assessments. Competency in risk management tools such as pFMEA and Process Hazard Analysis. Demonstrates knowledge in teamwork, project management, problem solving and risk management techniques High level of organizational skills and ability to manage multiple validation activities simultaneously Good social and communication skills Strong documentation skills to ensure traceability and compliance. Good knowledge of the English language (verbal and written) Experience with supply chain distribution and packaging Medical device industry experience Does this position sound like the next step in your career? Join a team that works together to find solutions that make a difference! Requisition ID: 620754 As a leader in medical science for more than 40 years, 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. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

Responsibilities

Actively participates as a quality core team member in a strategic site project, implementing quality standards and procedures. Supports process validation activities and participates in process risk analysis.