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BD (Tissuemed Ltd) · 1 day ago

Sr. Quality Manager - New Product Development

Sparks, MD

Full-time

Onsite

Senior Level, Lead/Staff

$144K/yr - $238K/yr

10+ years exp

BD is one of the largest global medical technology companies in the world. In this pivotal role, you'll develop and implement sophisticated design control and quality assurance processes across Class I-III instruments and reagents, ensuring our products meet the highest standards of excellence.

Health CareHospitalMedicalMedical Device

Responsibilities

Ensure effective execution of the quality engineering activities in support of new product development

Lead, develop, engage and mentor quality design assurance organization

Continuously improve quality processes and quality system with the goal of improving product quality, cost and customer satisfaction through implementation of DFSS, DFM, Risk Management and Reliability Engineering guidelines

Complete design transfer activities among manufacturing plants

Ensure effective and compliant quality operation for engineering change management, and other relevant aspects of the quality system as it relates to New Product Development activities

Lead implementation and utilization of quality tools such as six sigma, risk management, root cause analysis, and DOE

Qualification

Quality assuranceRegulatory complianceDesign controlsRisk managementQuality engineering sciencesRoot cause analysisLeadershipTechnical documentationIn-Vitro-Diagnostic knowledgeSoftware qualityCommunication skillsProject managementTeam leadership

Required

Bachelor of Science in Engineering, Science (Chemistry, Physics, etc.), or other relevant field

10 years of quality assurance or relevant experience

Experience as an interface in regulatory compliance audits such as the FDA, ISO, PAL, Anvisa and others

The ability to make timely critical decisions regarding product quality and/or quality system compliance

The ability to effectively lead teams and influence

A thorough understanding of 21 CFR 820, ISO 13485, and ISO 14971

The ability to prepare, and understand technical documentation such as Engineering Drawings, Quality System Procedures, Technical/Validation Studies, etc

The ability to assess and articulate risk when evaluating a situation

The ability to perform thorough investigations, identify the root cause(s) of an issue, and propose appropriate corrective action(s)

The ability to communicate effectively in writing and orally, to organize work, and to achieve results when working alone or in teams

Knowledge of WW medical device regulations and quality sciences with specific focus on Class III design

Excellent leadership, communication, organization and project management skills

Strong knowledge of design controls and risk management

Excellent knowledge of quality engineering sciences