Sr Engineer, Quality

Fresenius Kabi USA•North Andover, MA

22h•$145,000 - $155,000•Hybrid

About The Position

The Senior Engineer, Quality will play a key role in ensuring product excellence by analyzing, developing, implementing, and executing processes that uphold the highest standards of quality. This position provides technical project leadership and guidance across the validation, verification, commercialization, and life-cycle management of BU-INS-IVX infusion systems and related disposable products.

Requirements

B.S. degree in Engineering (materials, biomedical, or mechanical)
Minimum 8 years of specialized experience in a medical disposables/device products field or advance technical degree.
Experience in compliant practices of design control and medical device risk management.
Excellent verbal and written communication skills.
Strong leadership and project management skills.
Strong analytical capability and attention to detail.
Ability to operate independently and exercise good judgment.
Able to use electronic systems including IT equipment to carry out duties

Responsibilities

Develop and implement quality assurance processes for medical devices in compliance with industry standards and regulations, including: IEC/ISO 62304: Medical Device Software Lifecycle, 21 CFR 820.30: Design Controls, ISO 14971: Medical Device Risk Management, IEC 60601: Medical Device Electrical Safety, ISO 10993: Biological Evaluation of Medical Devices, IEC 62366-1: Application of Usability Engineering to Medical Devices
Assure thorough testing and validation of software and hardware systems to ensure they meet specified requirements and are free from defects.
Collaborate with cross-functional teams to define quality metrics, standards, and procedures throughout the software and product development life cycle.
Assist with cross-functional risk assessments and contribute to the creation of risk management plans related to software and product quality.
Review and assure that verification test plans, test cases, and validation protocols are complete and provide meaningful results to confirm design outputs meet design inputs.
Stay updated on industry trends, regulatory changes, and best practices in medical device software and product quality.
Participate in audits and inspections to ensure compliance with relevant quality standards and regulations.
Investigate and analyze reported product defects, providing detailed and accurate reports to support corrective and preventive actions (CAPAs).
Facilitate communication between development teams and regulatory affairs to address quality-related issues.
Contribute to continuous improvement initiatives by leading complaint investigations, CAPAs, and other corrective actions.
Review design specifications for clarity, testability, and regulatory compliance.
Participate in design reviews for new products and establish quality plans.
Facilitate pre- and post-market risk management activities.
Maintain accurate records to assure regulatory compliance throughout the product lifecycle
All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities