Quality Lead

Quality Lead#26-13069

North Chicago, IL

All On-site

Job Description

Responsibilities:

o 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.

o Assure proper integration and support of device regulations, drug regulations and as appropriate, biologics regulations. Responsible for compliance with company policies and procedures.

o 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.

Are you open to look at candidates who are willing to relocate? Yes

Years of experience/education and/or certifications required:

o Bachelor's Degree in relevant Engineering, Life Science or other technical discipline or equivalent job experience required.

o 5+ years of total combined experience. At least 3 years in Device Design Quality Assurance

What are the top 3-5 skills requirements should this person have?

o Deep understanding of DHF structure and traceability between DHF elements.

o Knowledge and a comprehensive understanding of combination products, medical devices and design controls.

o 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.

o Well-versed in risk management methodologies and their application.

o Work independently and in a global team environment, and with all levels of personnel within the organization.

What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?

Examples: Bachelor of Science; 4-year pharma, health care, or regulated industry

1. Systems Engineering experience

2. Relational database experience.

What type of environment is this person working in?

o Combination of both Group and Individual

Work Schedule (Define days,# of hours)/ Is Overtime offered or required? If yes, how many hours, what impact to scheduled working hours?

o 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.

Does this position offer the ability to work remotely on a regular basis or is it an on-site role? If remote opportunity exists, what are the options (i.e., 1 day remote, 4 days on-site)?

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

Is the worker onshore or offshore? Onshore

Will there be Domestic and/or International Travel? If yes, list proposed countries and % of time travelling: No

Reason for opening this role: Support of DHF reconfiguration project.

EEO:

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.