HireDiversity

Cincinnati, OH, US

SENIOR QUALITY ENGINEER-8388121029

Description

The Ethicon Surgical Care business a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Senior Quality Engineer, located in Cincinnati, OH.

The Ethicon Surgical Care business offers a broad range of products, platforms and technologies-including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices-that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and electiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.

The Senior Quality Engineer will be responsible for product team support for quality system design, implementation & auditing for compliance with EES, government regulations & international standards requirements. She/ He will support product development efforts by preparing quality plans, reviewing design plans & overseeing qualification & validation process

The Senior Quality Engineer will be responsible for Design Control: prepares Quality Plan for assigned products / projects. The individual will approve design specifications (e.g., drawings, protocols) as defined in signature matrix, will partner with affiliated disciplines (i.e., Regulatory Affairs, Clinical Affairs) to assure adequate design inputs are included, for example QFD (Quality Function & Deployment). For validation will define the QA system & assist in resolving all quality issues, allowing transfer of manufacturing processes to Operations. The Senior Quality Engineer will eliminate the need for post-cobalt product testing & release and will qualify products for multi-pass cobalt sterilization / product release. For regulatory: she/ he will provide guidance on compliance requirements for ISO, European MDD (Medical Devices Directive) & FDA (Food & Drug Administration) / QSR (Quality Systems Regulations). Will perform initial regulatory review for change control. Quality Engineering: the engineer will develop & maintain system to identify, bracket, correct & prevent defects to demonstrate product is ready to market & manufacture on an ongoing basis. The individual will provide statistical support for DOE (Design of Experiments), sampling plans, capability assessments & hypothesis tests. Will provide reliability objectives & assessment plans and support risk assessment activities: FMEA (Failure Mode Evaluation & Analysis) & FTA (Fault Tree Analysis), Assist suppliers in development of control plans, Review & report on analysis of field inquiry reports. The Senior Quality Engineer will assure consistency with other team QE's, site Quality Systems, & corporate Quality Systems. Moderate travel may be required. No direct reports

Other responsibilities may be assigned & not all responsibilities listed may be assigned

Qualifications


A minimum of a Bachelor degree is required. A degree in an Engineering discipline (i.e.: Mechanical, Electrical, or Industrial) or other closely related discipline would be highly preferred. Advanced degree is also a plus. A minimum of 5+ years related work experience is required, Experience in the medical device or other highly regulated industry is desired. Experience in auditing for compliance to ISO or GMP standards preferred. Certified Quality Engineer (CQE) Certified Reliability Engineer (CRE) and/or Certified Quality Auditor (CQA2) Ratings preferred. Experience auditing against ISO (International Organization for Standardization), QSR (Quality Systems Regulations) & GMP (Good Manufacturing Practices) standards desired. Process Excellence or Six Sigma training or certification or experience highly desired. Knowledge of Regulatory compliance preferred. Experience with GMP (Good Manufacturing Practices), MDD (Medical Devices Directive), or 510K (Pre-market Notification) preferred. Experience with Advanced quality systems (AQS) preferred. Reliability & quality engineering experience preferred. Experience with Statistics, Gage reliability & repeatability theory & applications are also preferences. Prior project management experience desired.

This position may require moderate levels of travel as needed by business. This position will be based 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)