Quality Engineer, Medical Devices
Location:
Posted:
September 17, 2016
Reference:
1038183


About the company
A career at the company offers opportunity, ownership and impact.

All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description
This posting is for a QO Technology Transfer Professional with a focus on Medical Device (Class 1-3) projects. The team supports technical project implementation in Kalamazoo, providing the project team with a Single Point of Contact (SPOC) for QO support, system implementation, and Design History File development and maintenance. Projects include plant network strategy transfers, new product implementation in Codevelopment with Research & Development, and internal Continuous Improvement and Organic Growth.

Responsibilities
Demonstrated knowledge of Medical Device guidances (e.g., ISO 13485, ISO 14971, MDD 93/42/EEC), cGMPs, compliance issues, industry quality assurance practices and systems, and personal management skills. Independently, with minimal guidance, coordinates and implements the quality systems integration of a variety of projects:
1) Support medical device projects through their lifecycle, including design, development, validation, launch, and post-marketing surveillance
2) Lead the development and change control of Design History File (DHF) documentation, including Failure Mode Effects Analysis (FMEA)
3) Conduct reviews of production and quality system documentation
4) Write non-conformances and support investigations
5) Coordinate communication with and notification to Notified Body and regulatory agencies

This position will also include quality systems set-up and support for the impacted QO systems, including Analytical Methods (e.g., AMTE), CMC-Site and Medical Device Compliance, Production, Validation, Raw Material and Packaging Material.

Qualifications
Must have at least a Bachelor degree in science and a minimum of 7 years of Quality experience in medical devices (Class 1-3) and/or pharmaceuticals, extensive knowledge of ISO 13485, strong understanding of industry standards and regulatory expectations. Experience in quality assurance and in supporting multiple Quality systems is preferred, such as analytical testing, method transfer, deviation investigation, raw and packaging materials, manufacturing support, process validation, site compliance and project management.

Must use the company leader behaviors in day to day interactions and have good people skills, in addition to proven written and oral communication skills.

PHYSICAL/MENTAL REQUIREMENTS

Office environment, with visits to manufacturing and laboratory areas, as needed to interface with team members and support manufacturing.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Position may require occasional travel, depending on project needs.

Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.

EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. the company is an E-Verify employer.
A little about us:
Join Pfizer in our mission to find sustainable solutions to the most urgent health care challenges of our time. Your service is needed.

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