Senior Engineer-Quality Systems Validation (Medical Devices)

EXPERIENCE IN MEDICAL DEVICE INDUSTRY IS A MUST.

Summary:

The primary purpose of the Quality System Engineer II Validation role is to support delivery of quality system software application validations in collaboration with IT and system owner cross functional teams. This role represents the quality (GQRA) function for software validation to ensure compliance with global software procedures, software standards, and regulations with regards to validation and documentation controls. The position has direct involvement with the introduction and maintenance of global software systems utilized to support GMP manufacturing.

This role is responsible for being the quality representative for computer system validations, development and execution of validation plans, protocols and testing documentation for compliant computerized systems in a GMP environment. The role will support the establishment of standard work practices and testing for the validation and ongoing maintenance of computerized systems and will support investigations, resolve potential data integrity issues, and implement process improvements to mitigate any risks to the validated state.

Responsibilities:

• Ensure all quality related computerized system applications are qualified in compliance with Hollister's Quality Management System requirements and procedures, FDA, European cGMP and GAMP standards.
• Collaborate effectively with global business partners across domain to ensure priorities are aligned with global standards and strategic objectives.
• Co-ordinate, provide guidance and actively participate as a project team member for software validation projects.
• Generation/maintenance of software validation plans, protocols and reports to cGMP standards and industry best practices.
• Review / approval of software validation plans, requirements, protocols/ test scripts and final reports.
• Management of software validation change control process.
• Serve as software validation SME providing guidance and direction to lead validation activities for software projects.
• Represent software validation team at both internal and external audits and at Quality System Management Reviews when applicable.
• Perform tasks as assigned by direct manager

Work Experience Requirements

• Number of Overall Years Necessary: 5+ years
• Experience working with computer systems, software validation, or related field is essential
• Computer Systems & Spreadsheet Validation experience and understanding of applicable regulations (Annex 11, GAMP, 21 CFR Part 11).
• Regulated environment, medical devices experience is preferable.
• Previous people management (direct or indirect) experience is preferable.

Specialized Skills/Technical Knowledge:

• Good knowledge and understanding of the medical device quality and regulatory requirements, including ISO13485, GAMP 5, IEC62304, 21CFRpart 820, part 11 as well as other Computer System Validation processes.
• Demonstrated working knowledge in the principles and effective implementation of software validation methodology.
• Experience in the review, evaluation and testing of systems to ensure compliance with FDA Electronic Records/Electronic Signatures regulations.
• Good overall knowledge with IT infrastructure and applications
• Experience of testing GAMP Category 3, 4 & 5 systems.
• Strong oral, written communication, and interpersonal skills.
• Ability to work closely with people at all levels of the organization and with persons from different cultural, language and regional backgrounds to accomplish assigned project goals.
• Must be results driven striving to meet all targets and prioritize/manage project deliverables.
• Experience interacting with auditors preferred