HireDiversity

Cincinnati, OH, US

SENIOR QUALITY ENGINEER ( 1of 2)-3752120831

Description

Ethicon Endo- Surgery, Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Senior Product Quality Engineer located in Cincinnati, OH.

Ethicon Endo-Surgery, Inc. develops and markets advanced medical devices for minimally invasive and open surgical procedures. The company focuses on procedure-enabling devices for the interventional diagnosis and treatment of conditions in general and bariatric surgery, gastrointestinal health, gynecology and surgical oncology.

The Senior Product Quality Engineer is responsible for support and leadership of Quality Engineering activities in of New Product Development, CAPA, and process improvement activities.

KEY JOB RESPONSIBILITIES:

Provide leadership in design & implementation of world-class quality engineering to support entire product life cycle with focus on quality engineering activities such as reliability, risk management, analytics/statistical techniques, requirements management, verification & validation, and design control across the lifecycle of the product. Activities would drive prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction. Provide leadership, technical expertise to ensure conformance to ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) based quality systems, Provide review and approval for the release of new products ensuring quality requirements are met Provide leadership & support to J&J process excellence initiatives including Six-sigma, design excellence & lean thinking. Direct development & consistent application of quality policies & procedures in product design & development, secondary development & transfer operations. Act as technical liaison, as needed, between product development, manufacturing, external manufacturers & suppliers. The candidate should have strong analytical problem solving skills and sound statistical application in areas such as DOE, sampling techniques, regression, reliability, FMEA, hypothesis testing, etc. Other responsibilities may be assigned & not all responsibilities listed may be assigned

Qualifications


A minimum of a Bachelor degree in Engineering is required. A degree in Mechanical, Electrical, Industrial, or Biomedical engineering would be preferred. A minimum of 5 or more years related work experience is required. Experience in a medical device or a regulated environment is highly desired. Experience in auditing for compliance to ISO or GMP standards preferred. Training or certifications in any of the following would be a plus: CRE (Reliability Engineer Certification), CQA (Quality Auditor Certification) and/ or CQE (Certified Quality Engineer). Experience with Reliability & quality engineering is required.

ADDITIONAL KNOWLEDGE REQUIREMENTS:

Advanced quality systems (AQS) experience preferred, Demonstrated experience working within a team, obtaining feedback, negotiating, and training is required. Excellent analytical & creative thinking, along with problem solving skills are a must. Prior experience working with Risk Analysis and Risk Management is also preferred. Excellent ability to develop new metrics, utilize statistical application in areas such as DOE, sampling techniques, regression, reliability, FMEA, hypothesis testing, etc preferred. Experience with project management and the ability to work with multiple simultaneous priorities in a highly matrixed environment is required. A demonstrated ability to positively influence cross-functional teams is required. Ability to understand new concepts quickly, research and maintain ongoing learning of industry regulations is required. Knowledge of: Regulatory compliance, GMPs, MDD (Medical Devices Directive), 510K (Pre-market Notification), PMA (Pre-market Approval), and Government, trade association, industry & medical publications desired. This position may require up to 20% domestic and international travel. This position will be located in Cincinnati, OH.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-Ohio-Cincinnati
Organization: Ethicon Endo Surgery Inc (6041)