Senior Design Quality Engineer – MedTech On-Site QA Leader

Regulatory Jobs; Covington (GA); Sur place; USD 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

ASQ Certification

Résumé du poste

BD, a global medical technology company, is seeking a Senior Quality Engineer to own QA/Document Control/Design Control within a product line. You will lead cross-functional teams in applying Design Control, author QA docs, and drive CAPA initiatives to improve product quality.

Responsibilities include leading risk assessments, validating processes, and auditing quality systems. You will mentor staff and collaborate with manufacturing sites to ensure regulatory compliance and continuous

Qualifications

• 5 years of FDA-regulated environment experience.
• 3 years of product design experience.
• 2 years of Quality Engineering experience in a regulated environment.

Responsabilités

• Serve as the Quality representative on cross-functional project teams, ensuring Design Control principles are applied to product and process changes and new development activities.
• Provide Quality Assurance leadership and guidance to project teams and within the Quality organization.
• Author, review, and approve Quality System documentation, including CAPAs, audit reports, and related quality records.
• Develop, review, and approve product quality documentation, including Design History Files (DHFs) and other design control deliverables.
• Create, review, and approve validation protocols and reports for products, processes, software, and stability studies.
• Lead and support risk management activities, including FMEA, FMECA, FTA, and other risk assessment documentation.
• Analyze product and process nonconformances, determine root causes, and drive CAPA plans.
• Perform internal and supplier quality system audits for regulatory compliance.
• Review and investigate product complaints, supporting timely resolution and continuous improvement.
• Monitor, track, and trend key quality metrics to identify risks and improvement opportunities.
• Partner with manufacturing sites to ensure consistent quality practices across operations.
• Serve as independent QA reviewer and chair Design Reviews for objective evaluation of product development activities.
• Mentor and develop quality professionals and engineers through coaching and knowledge sharing.
• Provide oversight and supervision for technicians and engineers, supporting performance and project execution.
• Maintain awareness of evolving industry trends and communicate insights to the business.

Connaissances

Detail oriented

Regulatory knowledge

Statistical analysis

Cross-functional collaboration

Formation

BS/MS Engineering (BME or EE or ME)

Description du poste

BD, a global medical technology company, is seeking a Senior Quality Engineer to own QA/Document Control/Design Control within a product line. You will lead cross-functional teams in applying Design Control, author QA docs, and drive CAPA initiatives to improve product quality.

Responsibilities include leading risk assessments, validating processes, and auditing quality systems. You will mentor staff and collaborate with manufacturing sites to ensure regulatory compliance and continuous