Systems Engineer

We're hiring on behalf of a Haystack partner!The Role• Serve as a senior subject matter expert and strategic contributor for critical Quality System processes including Quality System Strategic Planning (QSSP), Management Review, CAPA, customer complaints, and change management.• Lead cross-functional initiatives, drive quality system harmonization, and act as a process owner for core Quality Management System (QMS) elements.• Lead and mentor teams in complex root cause investigations and the development of effective corrective and preventive actions.• Partner with stakeholders to drive quality improvements tied to customer complaints and product issues.• Collaborate with management to support audit readiness, regulatory inspections, and gap remediation activities.• Lead QMS integration during mergers and acquisitions and represent Quality Systems in global initiatives.What You'll Need• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.• 10-15 years of Quality Systems or Quality Engineering experience in a regulated industry (medical device, biotech, or pharma).• Demonstrated leadership in owning and improving QMS processes.• Strong understanding of regulatory standards (FDA QSR, ISO 13485, EU MDR).• Proven expertise in root cause analysis techniques and risk-based decision-making.• Proficient in electronic QMS platforms.What's On Offer• Competitive annual salary ($80,800 – $111,100) plus bonus potential.• Comprehensive benefits package including health, dental, vision, and a generous 401(k) employer match.• Access to an onsite gym and cafeteria.• Opportunity to make a significant impact in a company dedicated to improving healthcare outcomes.Apply via Haystack today!