Regulatory Compliance Auditor

Advanced Sterilization Products is hiring for a hybrid Staff Compliance Auditor (Medical Device) position.

Your Impact

Want to use your audit and regulatory expertise to help teams minimize business impact? The Staff Compliance Auditor (Medical Device) position is your chance to do just that!

Collaborating with internal and external business partners, the Staff Compliance Auditor helps ensure continuous compliance with internal process requirements as well as applicable external standards and regulations.

This position primarily leads internal audits, supplier audits, external audit events, and associated audit activities, and regularly works with all levels of both internal and external personnel in order to identify and rectify potential compliance issues.

Additionally, this role routinely supports company-wide inspection readiness activities, QMS certificate management programs, Health Authority responses, continuous improvement initiatives, and other assigned projects.

Duties and Responsibilities

Audit Management:

• Establish and lead Internal Audit and Supplier Audit activities to ensure compliance to applicable government regulations, material specifications, international standards, and company policies and procedures.
• Leads or supports Front Room/Back Room operations during external audit/inspection events.
• Plans, completes, and maintains audit files including but not limited to: Audit Schedule(s), Audit Plan(s), Audit Report(s)
• Leads the collection and review of Audit Action documentation, including but not limited to: Root Cause Investigations, action plans, and associated objective evidence
• Provides general Quality Compliance guidance and direction to peers and other business partners.
• Generates data for Management Review and identifies trends and/or concerns for site management and/or global leadership, as applicable.
• Stays updated on regulatory changes through industry publications, seminars, participation in trade organizations and/or government meetings, as applicable.
• Evaluates processes and implements process improvements, as needed.

External Audits/Inspection Readiness:

• Establish, evaluate and maintain the external audit readiness program to ensure the quality management systems are operating in compliance; develop and manage plans; conduct walkthroughs, and develop and deliver required training. Research emerging regulatory trends and changes in regulations and standards to incorporate into the business to ensure ongoing readiness to these requirements.

Certificate Management:

• Establish, evaluate and maintain the process for certificate management. This includes retention, periodic review, posting, and responding to requests for certificates from internal/external customers.

Health Authority Monitoring:

• Coordinates and supports Health Authority requests received from senior management and internal/external customers to respond to requests for information to ensure an aligned and consistent response.

Travel:

• 20% – 60% travel as needed for audit purposes. Majority local travel with occasional domestic and international trips.

Education and Years of Experience

• Bachelor’s Degree in a technical or science related field required.
• 7 or more years of related experience and/or training; or MS with 5 or more years; or Ph.D. with 3 or more years.

Knowledge, Skills, and Abilities

• Responding to medical device or pharmaceutical external agencies.
• FDA 21 CFR Part 820, FDA 21 CFR Part 11, QSR, ISO 13485, SOR 98-282 CMDR (Canada Medical Device Regulations, J-PAL (Japanese), MDD (European) requirements, EU MDR, Brazil GMP, and MDSAP audit program.
• Teamwork, collaboration, and influencing skills; demonstrated initiative and assertiveness.
• Strong project management skills.
• Proficiency in MS Windows, MS Office (Word, Excel, PowerPoint).
• Strong written and oral communication skills.
• Ability to conduct and manage audits required.
• Ability to read, analyze and interpret scientific and technical journals, financial reports, and legal documents.
• Ability to select, manage and guide a team during an audit.
• Ability to respond to common inquiries, regulatory agencies, or members of the business community.
• Strong statistical skills and manufacturing process understanding.
• Ability to lead a team through a root cause analysis problem.
• Ability to write speeches and articles for publication that conforms to prescribed style and format.
• Ability to effectively present information to top management, public groups, and/or boards of directors.
• Ability to build partnerships both internally and externally.
• Ability to effectively work with governmental and independent auditors.
• Expertise in dealing with the Food & Drug Administration.
• Knowledge and skills in quality-related methods and techniques including auditing principles and techniques, quality terminology, quality management principles and their applications, and quality management tools and their applications.
• CQE and/or CQA, ASQ CQA certification preferred.

This job description is intended to convey information essential to understanding the scope of this position and it is not intended to be an exhaustive list of skills, efforts, duties, responsibilities or working conditions associated with the position. Employees are required to follow any other job-related instructions and perform job-related duties as may be reasonably assigned by their supervisor. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential duties of the job.

Job Requirements:

ASP is a leading global provider of innovative sterilization and disinfection solutions, and a pioneer of low-temperature hydrogen peroxide sterilization technology.

ASP’s mission is to protect patients during their most critical moments. We support healthcare facilities protecting patients against hospital acquired infections, which are a leading cause of morbidity and mortality.

We are always leaning into the next challenge, imagining the next breakthrough, and crafting the next innovation. At ASP, we believe in you. We believe in your potential – your ability to learn, grow, and contribute in meaningful ways.

We believe in the power of phenomenal people working together to innovate and solve problems no one could tackle alone.

We are Advanced Sterilization Products.

Fortive is a global family of more than 20 industry-leading industrial growth and technology companies, united by a shared purpose: to make the world stronger, safer, and more effective by providing essential technology for the people who accelerate progress. Here, you get the excitement of a “startup” with the stability and predictability of an organization strongly grounded in its roots and with a proven track record of growth. There’s no limit to what you can learn, or the impact you can make: for you, for us, for growth.

Come join our team at Advanced Sterilization Products (ASP) and be part of a global leader in infection prevention solutions for the healthcare industry. With advanced products, technologies, and workflows for medical sterilization and disinfection, ASP is dedicated to defending the lives of patients, families, healthcare workers, providers, and communities. Add your talent to our extraordinary team and help us in our mission to make healthcare safer for everyone. ASP is based in Irvine, California with core sites in Everett, Washington and Schaffhausen, Switzerland plus many more offices around the world.
We Are an Equal Opportunity Employer

Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law.

Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment process should ask to speak with a Human Resources representative to request an accommodation.