Quality Engineer II Job Covington area,Kentucky USA,Quality Assurance

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Job Description

Position Summary:

The Quality Engineer is responsible for a broad range of quality engineering activities and serves as the owner of Quality Assurance, Document Control, and Design Control processes within their product line. This role partners closely with Manufacturing, R&D, Product Development, and Quality teams to ensure compliance with quality system requirements while supporting new product development, product changes, process improvements, and ongoing quality initiatives.

Responsibilities:

Serve as the Quality representative on cross-functional project teams, ensuring Design Control principles are applied throughout product and process changes as well as new product development activities.
Provide Quality Assurance leadership and guidance to project teams and the broader Quality organization.
Develop, review, and approve Quality System documentation, including CAPAs, audit reports, and related quality records.
Create, review, and approve product documentation, including Design History Files (DHFs) and supporting design documentation.
Develop, review, and approve validation protocols and reports, including process, product, and stability validations.
Create, review, and approve risk management documentation, including FMEA, FMECA, and Fault Tree Analysis (FTA).
Investigate product and process nonconformances and lead corrective and preventive action activities to drive sustainable improvements.
Conduct internal quality system audits and supplier quality audits to ensure compliance with regulatory and company requirements.
Review and investigate customer complaints as needed, ensuring timely and effective resolution.
Monitor, analyze, and trend key quality metrics and performance indicators to identify opportunities for improvement.
Partner with manufacturing sites and other division facilities to support quality objectives and continuous improvement efforts.
Serve as the independent Quality Assurance reviewer and Chairperson for Design Review activities.

Required Qualifications:

Bachelor's of Engineering (BME or EE)
2 years of Quality Engineering experience in a regulated environment
Ability to travel internationally up to 15%

Preferred Qualifications:

Masters of Engineering
ASQ Certification

Knowledge and

Skills:

Regulatory knowledge and experience including but not limited to FDA, MDSAP, PMDA, CFDA
Demonstrated experience working with international suppliers/manufacturers as it relates to product quality and reliability
Demonstrated history of successfully interpreting regulations, and procedures
Demonstrated skill in statistical analysis and applied statistical methodologies

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some…