Senior QA Specialist

Role

This is an extraordinary career opportunity for a Senior Quality Assurance (QA) Specialist who will be responsible for supervising and leading business activities to ensure a state of continuous compliance. In this role, you will routinely work with internal and / or external business partners mainly in EMEA and APAC regions for internal and supplier audits, to ensure that departments and functional areas are prepared to support external agency inspections to minimize compliance risk(s).

Location: Europe - remote

• Owns the Inspection Readiness program to ensure the Quality Management System (QMS) operates in a state of continuous compliance. Program activities include developing and delivering Inspection Readiness training, performing Gemba walks of operation sites / facilities to identify compliance risks, and facilitating corrective action plans.
• Perform Internal Audits and / or Supplier Audits and associated activities to ensure continuous compliance across the organization, including the scheduling, planning, execution, reporting, and follow-up of audit activities. May also include fulfillment of requests for directed audits, as determined by management and / or business partners.
• Perform External Audit / Inspection activities hosted by the organization and / or affiliates.
• Leads Health Authority notification response activities, as determined by management and / or business partners.
• Maintains QMS and / or product certificates for the organization, including the retention, review, and posting of certificates, as well as fulfillment of internal and / or external requests for certificates.
• Maintains audit reports and metrics to support communications to organizational leaders and / or business partners.
• Researches and incorporates emerging regulatory trends and changes in regulations and / or standards to ensure continuous compliance. May also include attendance at industry seminars, participation in trade organizations, and government meetings.
• Provides direction and guidance to auditors-in-training and / or leveraged auditors.
• Evaluate business processes and implement process improvements, as appropriate.
• May perform special projects or other duties, as determined by management and / or business partners.

• Bachelor's Degree
• Min. of 5 years of Experience in Quality Management Systems (QMS) and Internal and Supplier Auditing Experience
• ISO 13485 : 2016 Lead Auditor Certification
• Knowledge of Medical Device Standards and regulations (Ex. ISO
  13485 : 2016, FDA CFR 820, EUMDR, MDSAP)
• Auditing technical knowledge
• Fluency in English
• Excellent written, verbal communication and presentation skills
• Ethical judgment, adaptability and continuous improvement

We thrive in diverse work environment and offer inclusive benefits including attractive paid time off and extra work-life balance week in the US, flexible schedules, parental leave & parental benefits in some regions.

Spread across multiple geographies and diverse teams the ASP culture is deeply rooted in our ASPirational4 values – customer obsessed, courageous, build extraordinary teams and deliver results. Being part of Fortive is a commitment to continuous improvement and aspiring for better every day. It’s facing challenges head on, speaking your mind, and being yourself. It’s working together for a sustainable future.

It’s celebrating wins and learning from failures as a team.