Senior Compliance Auditor Details

Senior Compliance Auditor

Smiths Medical - Minneapolis, MN

Employment Type : Full-Time

Job Description

Smiths Medical is currently hiring a Senior Compliance Auditor in Minneapolis, MN.

The Senior Compliance Auditor will be responsible for performing Corporate audits across Smiths Medical sites globally. This person will ideally already be a certified ISO 13485 lead auditor. This role will ensure that the Smiths Medical Quality Manual, Policies, Procedures and Global Work Instructions have been implemented at Smiths Medical Sites. Additionally, this position will ensure audit is conducted based on the risk to patients through product and process risk evaluation, and risk to the site and/or Smiths Medical divisionally through compliance assessment.

Smiths Medical has a positive impact on someone’s life around the world every minute of every day. In fact, over 240 people every minute benefit from a Smiths Medical product. Join us and grow your career while being a part of our continued success! We offer a fun, fast-paced, inspiring and collaborative work environment with opportunities to learn and contribute at all career levels. Innovation is part of who we are, with industry-leading products across a broad spectrum of medical device categories and a strong new product development pipeline.

• Perform corporate audits according to schedule, for the various Smiths Medical sites globally per Smiths Medical Policy.
• Perform post-audit follow up of non-conformances written, including timely review of investigation, corrective action plan, and all necessary closure documents.
• Executing supplier audits of Smiths Medical’s supply base; including but not limited to, raw materials, components, virtual manufacturing, sterilization, or testing, software, warehouse/distribution suppliers.

• Resolve Supplier Corrective Actions (SCAR) in a timely manner, as an output of supplier audits.
• Identify compliance risks and escalate issues to appropriate levels of management for resolution.
• Act as a subject matter expert (SME) in support Smiths Medical internal and external QMS audits, as it relates to, supplier audit and evaluation questions.
• Provide sites with audit/inspection readiness preparation and support during external audits, either in person or remotely as needed.
• Maintain professional certification as Lead Auditor, Quality Auditor (CQA), Quality Engineer (CQE), and knowledge in applicable regulations/standards. Between to 50-65% travel requirement.
• Provides compliance expertise for the Division by interpreting government regulations and standards as they apply to the Quality Management System and provide training and consulting. The incumbent will also be required to interface with all sites and functions globally to provide compliance advice on regulations and standards for the Quality Management System.
• Support the department manager in preparing and presenting data for internal and external audits.
• Conducts project work as required by the management to complete team activities and achieve team objectives. May perform additional related duties as assigned.
• This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site).
• Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.

We believe that different perspectives and backgrounds are what make a company flourish. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, economic status, disability, age, or any other legally protected characteristics. We are proud to be an inclusive company with values grounded in equality and ethics, where we celebrate, support, and embrace diversity.

• University Degree (BA degree) required.
• ISO 13485 lead auditor certification.
• Four (4) years minimum of direct experience in Medical Device Quality or Compliance (multi-site Medical Device organization experience preferred).
• Strong working knowledge of current international and company regulatory compliance requirements and operating procedures, including (but not limited to) FDA, ISO 13485, MDSAP, European Medical Device Directive and Medical Device Regulation, and applicable industry Standards.
• Demonstrated proficiency at critically reviewing quality documentation and records (e.g. procedures and completed records).
• Demonstrated proficiency in technical writing and development of standard operating procedures.
• Effective facilitation skills to lead discussions around audit findings, driving to consensus and resolution of identified non-conformances.
• Effective facilitation skills to lead large group training sessions at sites across the organization.
• Project management skills, to lead large projects to completion, on time, on budget, with appropriate escalation of risks to management.
• Proficient computer skills including electronic mail, project management, record keeping, and routine database activity, word processing, spreadsheet, graphics, etc.
• Excellent verbal, written, and presentation communication skills. High attention to detail.
• Education requirements can be obtained through an educational institution or gained through equivalent work experience.

In addition to a competitive compensation package, Smiths Medical offers a comprehensive benefit package including Medical, Dental, Vision, 401K and much more!

At Smiths we apply leading-edge technology to design, manufacture and deliver market-leading innovative solutions that meet our customers' evolving needs, and touch the lives of millions of people every day. We are a FTSE100, global business of around 23,000 colleagues, based in 55 countries. Our solutions have a real impact on lives across the planet, enabling industry, improving healthcare, enhancing security, advancing connectivity and supporting new homes. Our products and services are often critical to our customers’ operations, while our proprietary technology and high service levels help create competitive advantage. We welcome colleagues with a curious mind, who are happy with responsibility, enjoy a challenge and are attracted by the idea of working at a business with an almost 170 year history of innovation, and five global divisions, all experts in their field.

Smiths Medical is always looking for people with a passion to positively impact the health and wellbeing of people around the world. If you have a curious mind, relish a challenge and want to make a difference then bring your talents here and your opportunities are endless. We're proud that we've been helping propel the human world forwards during our 160-year history of innovation. By looking at things differently. By adapting and never standing still. And by always thinking big we have introduced some of the most trusted brand names in healthcare. Today we're an aligned global business 8,000 colleagues, that touches the lives of 7 people every second across the globe. So whether you're an experienced professional or just starting out on your career, our global scale and focus on growth means great career opportunities for the right colleagues. There's never been a better time to join Smiths. And help us create the future.