Job description
Summary:
The Senior Design Assurance Quality Engineer functions as a project core team member, representing Quality Management on new product development and change management projects, committing to support product / project objectives, driving and participating in business decisions, and assuming accountability for product / project success. The Senior Design Assurance Quality Engineer also employs project management methods to serve as an interface between a cross-functional extended core team and the project core team leader on new product development projects. The position independently evaluates, selects and applies standard quality techniques, procedures and criteria, using judgment in making decisions on clear and specified objectives, and will implement best practice procedures to clarify work processes. The Senior Design Assurance Quality Engineer will also take leadership roles in projects and programs, create teams, and establish objectives for the team. In ensuring that team objectives are met, the position will identify specific action steps and accountabilities, clarify roles and distribute work load and responsibilities to appropriate individuals. The position will monitor progress of others and redirect their efforts when goals are not being met.
The Senior Design Assurance Quality Engineer functions as a project core team member, representing Quality Management on new product development and change management projects, committing to support product / project objectives, driving and participating in business decisions, and assuming accountability for product / project success. The Senior Design Assurance Quality Engineer also employs project management methods to serve as an interface between a cross-functional extended core team and the project core team leader on new product development projects. The position independently evaluates, selects and applies standard quality techniques, procedures and criteria, using judgment in making decisions on clear and specified objectives, and will implement best practice procedures to clarify work processes. The Senior Design Assurance Quality Engineer will also take leadership roles in projects and programs, create teams, and establish objectives for the team. In ensuring that team objectives are met, the position will identify specific action steps and accountabilities, clarify roles and distribute work load and responsibilities to appropriate individuals. The position will monitor progress of others and redirect their efforts when goals are not being met.
Responsibilities:
- Guide cross-functional teams in the appropriate application of design controls in compliance with global regulatory requirements for medical devices.
- Facilitate project quality activities addressing design and process verification / validation for new products and significant changes to existing products or processes.
- Facilitate design FMEA, participate in process FMEA, and conduct risk assessments in compliance with ISO 14971.
- Interface with Hollister plant and supplier Quality Engineering and Quality Assurance for new products and significant changes to existing products or processes.
- Utilize parametric and nonparametric statistical analysis methods (ANOVA, DOE, hypothesis testing, power analysis, process capability analysis, quality control charts, regression analysis, survival analysis, measurement system analysis, acceptance sampling) to ensure products/processes are appropriately characterized and qualified prior to market release.
- Support review of Preproduction and First Article submissions from the Hollister plants and suppliers for new products and significant changes to existing products or processes.
- Mentor and train others on subject matters related to principles and practices of Quality Engineering.
- Participate in internal, supplier, and external regulatory agency audits / inspections as required.
- General office environment - position may require sitting at a desk / computer for extended periods of time.
Work Experience Requirements
- Number of Overall Years Necessary: 8-12
- Experience in medical device industry. Background in Quality Engineering and/or New Product Development/R&D.
Education Requirements
- Bachelor of Science degree or higher in Engineering or Physical Sciences
- ASQ Certified Quality Engineer and/or ASQ Certified Reliability Engineer strongly preferred
- ASQ Certified Manager of Quality / Operational Excellence or Six Sigma Black Belt certificate is a plus
Specialized Skills/Technical Knowledge:
- Experience with the FDA Quality System Regulation and ISO 13485 environment at a medical device manufacturer.
- Project management training and experience.
- Experience with product development, design controls, and risk management for medical devices (ISO 14971).
- Desirable: Advanced statistics training and experience with plastic injection molding and automated assembly processes.
Hollister Incorporated is an independent, employee-owned company that develops,manufactures, and markets healthcare products worldwide. The company develops and manufactures products for ostomy care, continence care and critical care, and also develops educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, it has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider Inc (JDS Inc), a 100 year old company. Hollister is guided by the shared Mission of JDS Inc, to make life more rewarding and dignified for people who use its products and services.
www.Hollister.com
Hollister is an EO employer – M/F/Veteran/Disability
Job Req ID: 31004
Job Segment: Quality Assurance, Systems Analyst, Compliance, Project Manager, Product Development, Technology, Legal, Research
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