Senior Engineer, Quality (Medical Devices)

Location: Round Lake, Illinois, United States. Hybrid workplace with a required minimum number of onsite days each week.

Salary: $96,000–$132,000 annually, plus potential discretionary bonuses.

Company

hirify.global develops healthcare products and solutions focused on improving healthcare delivery and sustaining lives.

What you will do

• Lead post-market risk assessments of product issues and determine the need for action.
• Lead product performance investigations through failure analysis of complaints and product-related trends.
• Lead or participate in Complaint, Change Control, and CAPA Review Boards.
• Support cross-functional readiness for internal and external audits and inspections.
• Provide Quality support for R&D and laboratory studies, investigations, and instrument qualification activities.
• Serve as a Quality Core Team member for new and improved product design, implementation, NPD, and SPO development activities.

Requirements

• BS degree in Engineering or Science with 3–5 years of related Quality or Engineering experience, or demonstrated equivalent performance.
• Master’s degree may substitute for two years of related experience.
• Experience with quality systems and ISO requirements.
• Working knowledge of environmental, safety, and regulatory compliance in a regulated manufacturing environment.
• Ability to influence decisions, facilitate cross-functional teams, solve ambiguous problems, and account for business, cost, and engineering considerations.
• Applicants must already be authorized to work for any employer in the United States; visa sponsorship is not available.

Culture & Benefits

• Mission-driven environment focused on saving and sustaining lives.
• Culture emphasizing courage, trust, collaboration, ownership, and accountability.
• Medical and dental coverage beginning on day one, plus life, disability, and travel accident insurance.
• 401(k) plan with company matching, employee stock purchase plan, flexible spending accounts, and educational assistance.
• Paid holidays, 20–35 days of paid time off based on tenure, family and medical leave, and paid parental leave.