Sr. Quality System Engineer

Primary Function of Position

Lead complex QMS compliance projects, risk assessments, remediation plans, policy implementation, and quality plan execution across functions or sites.

Define implementation approach, deliverables, governance, risks, success criteria, and escalation pathways.

Provide senior-level review of QMS changes, procedures, training plans, records, dashboards, and implementation evidence.

Lead cross-functional meetings, align stakeholders, remove barriers, and drive action closure.

Mentor junior specialists and provide technical guidance on QMS compliance execution.

Support regulatory inspections, notified body audits, industry reviews, client reviews, and executive updates.

Drive process standardization, compliance technology adoption, digital workflow improvements, and continuous improvement.

Qualifications

• Required Skills and Experience:
  • 6 to 10 years of experience in Quality Systems, Compliance, Regulatory, Engineering, Operations, or a related field.
  • Strong knowledge of medical device QMS requirements and regulated change implementation.
  • Experience leading cross-functional QMS projects, policy implementation, risk assessments, remediation activities, audit readiness, or inspection support.
  • Strong technical writing, risk-based thinking, stakeholder management, executive communication, and project leadership skills.
  • Ability to coach junior team members and influence cross-functional teams without direct authority.
  • Ability to translate regulatory and procedural requirements into practical implementation plans.
• Required Education And Training:
  • Bachelor’s degree in engineering, Life Sciences, Quality, Regulatory Affairs, Compliance, or related discipline.
  • Equivalent combination of education and relevant experience may be considered.
  • Advanced degree or professional certification preferred.
  • Training in medical device QMS requirements, quality planning, audit support, risk management, project leadership, remediation management, and Good Documentation Practices required.