Description
Oversee Quality Engineering, Validation, Quality Control, Calibration, Quality Systems/Compliance and Sterility Assurance functions. Support the design and development of biomaterials and regenerative biological products, development and improvement of associated manufacturing processes and support of shop floor continuous quality improvement initiatives.Essential Duties & Responsibilities
* Review regulatory compliance requirements for changes affecting device manufacturing in global markets including GMP's, European Community Medical Device Directive, ISO 9001, and ISO 13485. Implement quality system changes to support evolving regulations and international standards.
* Provide a strategic direction and tactical focus to the Operations Quality Assurance organization
* Oversee Malvern operations Quality Assurance activities, such as quality control, validation, calibration, sterility science and assurance, design and document controls, compliance and operating control.
* Ensure that manufacturing, product development and related functions are conducted in compliance with international standards and government regulations.Desired Skills and Experience
Education and Special Training Required Bachelor's Degree in Engineering or other relevant field of study.
Prefer Six Sigma experience and CQE/CQM/PE certification; also prefer Master's Degree in related field.
Qualifications and Work Experience Required * 10-15 years relevant experience in a manufacturing and product development environment
* Applied knowledge of regulatory requirements, including ISO 9001, ISO 13485, Quality System Regulation and Medical Device Directive
* Demonstrated expertise in quality assurance systems in a regulated environment.
* Applied knowledge and application of quality tools, such as FMEA, SPC/Process Control, Root Cause Analysis
* Prefer applied knowledge of Six Sigma methodologies
* Demonstrated project management skills
* Demonstrated ability and experience managing staff
* Demonstrated verbal, written and interpersonal skills
* Demonstrated ability to work in a team environment, interact effectively with management from other functions (internally and externally)
* Demonstrated ability to manage a multi-discipline, multi-technology, team-based organization and assume responsibility for achievement of quality, regulatory and compliance targets
* Demonstrated ability to initiate work
* Demonstrated analytical ability
* Demonstrated ability to make effective decisions