Quality Systems Specialist

TL;DR

Quality Systems Specialist (Cardiac Surgery): Provide oversight for development and maintenance of quality programs, systems, processes ensuring compliance with internal and external standards. Focus on audit and inspection preparation, resolution of findings, process analyses, and facilitating uniform global standards.

Location: Onsite in Dexter, Michigan, United States. Minimum 4 days a week onsite. Requires unrestricted U.S. work authorization; no sponsorship for this level.

Salary: $72,800 - $109,200 USD

Company

Global leader in healthcare technology, focusing on cardiac surgery solutions including ECMO for patients worldwide.

What you will do

• Oversee development and maintenance of quality programs, systems, processes, and procedures for compliance.
• Provide expertise on policies, regulations, and guidelines to ensure adherence.
• Conduct process analyses with operating entities to enforce requirements.
• Lead audit and inspection preparation, resolve findings, and liaise with auditors.
• Prepare reports, documentation like CAPA, and coordinate legal requests.
• Maintain and update quality assurance programs, facilitating best practices globally.

Requirements

• Bachelor's degree with 2+ years in Quality or regulated industry, or Advanced degree.
• Degrees from outside US must satisfy 8 C.F.R. § 214.2(h)(4)(iii)(A).
• Unrestricted U.S. work authorization required at hire and throughout employment; no sponsorship.

Nice to have

• Experience with CAPA, QMS, and audits.
• Knowledge of Agile, Trackwise, SAP.
• Yellow/Green belt certification or Lean/Six Sigma equivalent.

Culture & Benefits

• hirify.global Mindset: Act boldly, compete to win, foster belonging, deliver results.
• Competitive salary, hirify.global Incentive Plan (MIP), 401(k) with match.
• Health, dental, vision insurance, HSA, FSA, life insurance, disability, PTO, holidays.
• Tuition reimbursement, employee stock purchase, assistance programs.
• Minimum 4 days onsite for collaboration and growth.