Quality Systems Engineer II Leader
hace 6 días
At Boston Scientific, we're a global leader in medical science with over 40 years of experience solving challenges that matter most. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives and create value for our customers.
We're seeking a highly skilled Quality Systems Engineer II to join our team in [location]. As a leader in this role, you'll be responsible for providing process/quality engineering support to the quality system function, ensuring the delivery of high-quality products or new products to customers.
Your key responsibilities will include:
- Supporting, planning, conducting, and overseeing internal system audits according to applicable regulations to assess the effectiveness of the QMS and identify areas for improvement.
- Maintaining audit records, findings, and corrective actions.
- Following up on deadlines of planned corrective and preventive actions plans, and initiating escalation when necessary.
- Generating reports on quality performance and trends, providing insights to management for decision-making.
- Collaborating with cross-functional teams to identify areas for process improvement and implement corrective and preventive actions (CAPAs).
- Acting as a CAPA Coordinator for the site, providing guidance to owners about the CAPA process and eCAPA system, conducting CAPA Review Board, and reporting required information to different forums.
- Supporting external audit readiness and participation in scheduled external audits for the site.
- Working closely with business system process owners to drive continuous improvement.
- Using data analysis and key performance indicators (KPIs) to drive continuous improvement initiatives within the industrial sector.
- Improving, developing, and delivering training programs related to the QMS, ensuring employees understand and adhere to quality standards and procedures.
- Serving as a Subject Matter Expert (SME) for Control of Documents, Internal Audits, Management of Non-Conformities, Problem Solving, Management Review, and Training for IDL.
- Staying current with industry trends, regulations, and best practices to ensure the company's quality systems are up to date, providing input for continuous improvement strategies to support manufacturing quality, cost reduction goals, and standardization of processes.
- Understanding and tracking quality plans, documents, and systems by reviewing product and process specifications and quality systems requirements.
- Conducting onboarding training sessions for new employees.
- Becoming familiar with product/process improvement efforts by understanding current quality metric data and learning various analysis methods used to enhance sustaining and improve the quality system.
- Checking and providing support in the execution and investigation of CAPAs, NCEP, etc.
The ideal candidate will have a Bachelor's degree in chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering, or a related field. English language proficiency at B2 level (70-79%) is required. Desirable knowledge includes ASQ certification (CQE, SSGB), ISO standards, MDSAP, medical devices regulation. At least 2 years of experience in a similar position is preferred.
Estimated salary range: $80,000 - $110,000 per year.
We offer a collaborative culture driven by a passion for innovation, a hybrid workplace including WFH and onsite opportunities, and a comprehensive benefits package including Life-Work Integration, Community, and Career Growth opportunities.
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