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 How you will contribute to ASP:

• 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.

  What will make you thrive in this role:

• 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. ISO13485:2016, FDA CFR 820, EUMDR, MDSAP)

• Auditing technical knowledge

• Fluency in English

• Excellent written, verbal communication and presentation skills

• Ethical judgment, adaptability and continuous improvement

  Inclusive Benefits

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.

Our Culture

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.

Fortive Corporation Overview

Fortive’s essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance, industrial condition monitoring, next-generation product design, and healthcare safety solutions.

We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in software-powered workflow solutions, data-driven intelligence, AI-powered automation, and other disruptive technologies. We’re a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to groundbreaking sustainability solutions.

We are a diverse team 18,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact.

At Fortive, we believe in you. We believe in your potential—your ability to learn, grow, and make a difference.

At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone.

At Fortive, we believe in growth. We’re honest about what’s working and what isn’t, and we never stop improving and innovating.

Fortive: For you, for us, for growth.

Ready to move your career forward? Find out more at careers.fortive.com (https://stgfortive.taleo.net/enterprise/careers.fortive.com) .

At ASP, we celebrate a culture that values collaboration, diversity, continuous-learning, and employee well-being. We are proud of our inclusive and supportive environment, and we look forward to welcoming candidates who share our values and are ready to contribute to our shared purpose and success.

ASP is a leading global provider of innovative sterilization and disinfection solutions, and a pioneer of low-temperature hydrogen peroxide sterilization technology. Our mission is to protect patients during their most critical moments. We support healthcare facilities in the fight against hospital acquired infections, which are a leading cause of morbidity and mortality. ASP’s products, which are sold globally, include the STERRAD system for sterilizing instruments and the EVOTECH and ENDOCLENS systems for endoscope reprocessing and cleaning.

Learn more about ASP here.