Quality Lead

About

This role serves as the primary quality lead for project activities to achieve on-time quality deliverables, high customer value, and profitable results. It is the primary driver for the quality and compliance aspects of the project.

Responsibilities

• Serves as the primary quality lead for project activities to achieve on-time quality deliverables, high customer value, and profitable results.
• Primary driver for the quality and compliance aspects of the project.
• Assure proper integration and support of device regulations, drug regulations and as appropriate, biologics regulations.
• Responsible for compliance with company policies and procedures.
• Ensure design control documentation (Traceability/Linkages) & design change control requirements are met.
• Assess the impact of a change on the safety, efficacy of the combination product/device.
• Analyze and justify the impact on cumulative changes.

Requirements

• Bachelor's Degree in relevant Engineering, Life Science or other technical discipline or equivalent job experience required.
• 5+ years of total combined experience.
• At least 3 years in Device Design Quality Assurance
• Deep understanding of DHF structure and traceability between DHF elements.
• Knowledge and a comprehensive understanding of combination products, medical devices and design controls.
• Sound technical understanding of product development (e.g. approaches for definition of requirements and specification setting for verification and validation) and/or practical experience in design control.
• Well-versed in risk management methodologies and their application.
• Work independently and in a global team environment, and with all levels of personnel within the organization.

Nice to Have

• Systems Engineering experience
• Relational database experience.

Work Environment

• Combination of both Group and Individual

Work Schedule

• 40 hour work week, start and end time negotiable but would like good overlap with core business hours 8:30 – 4:30 central.
• Overtime is possible in extenuating circumstances but is not typically allowed.

Remote Policy

• If located in lake county, expectation that hybrid Tues – Thurs in office hours are held. If remote, visit lake county 1 wk/month.

Other Information

• Onshore
• No Domestic and/or International Travel
• Reason for opening this role: Support of DHF reconfiguration project.

Interview Process

• Phone and video interview. Will meet in person if in Lake County.
• Involved in interview process: Sean Cradick, contact information in email signature, Lake County, IL.