Senior Quality Assurance Engineer
hace 2 días
At Baxter, we are committed to saving and sustaining lives through innovative medical solutions. As a Principal Engineer - Product Quality/Design Assurance, you will be an integral part of our R&D project teams, ensuring the highest quality and product safety in our sophisticated medical devices.
Responsibilities:
- Participate in Design Assurance improvement initiatives to enhance the overall quality of new product designs and our regulatory compliance profile.
- Interact with and influence project team members and leaders to ensure compliance with Design Control and Quality System elements.
- Prepare, manage, and update Design Assurance required sustaining engineering deliverables.
- Ensure product development activities related to verification and validation are fully compliant with quality system procedures.
- Assist in identifying and mitigating product or process-related risks.
- Support the CAPA and FA process by performing investigations, root cause analyses, and verification of effectiveness checks for design-related issues impacting the field.
- Support internal and external regulatory and customer audits.
Requirements:
- B.S. in Engineering, preferably Mechanical, Electrical, Electronics, or Computer Engineering.
- 5+ years' experience in medical device or other regulated technical industry in a design/development/quality role.
- Product Design experience may be considered in lieu of Quality Assurance experience.
- Knowledge of Quality System Regulations, Medical Device Directive, and ISO Quality System Standards.
- Knowledge of 21 CFR 820.30, ISO13485, IEC62304 desirable.
- Ability to perform and influence in cross-functional team environments and utilize effective interpersonal skills.
Baxter is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive work environment that values diversity and promotes equal opportunities for all employees.
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