Senior Compliance Auditor at Smiths-Medical in Minneapolis, Minnesota

Job Description:

* Job Search

* Save Search

SENIOR COMPLIANCE AUDITOR

Location
North America, USA, Minnesota, Minneapolis

Job Reference
MEDNA01010

Job Function
Reg Affairs & Quality Assurance

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 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. Duties & Responsibilities

* 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.

Diversity & Inclusion

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. The Individual

* University Degree (BA degree) required.

* 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.

Salary & Benefits

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

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. About Smiths Medical

Smiths Medical is always looking for people with a passion to positively impact the health and wellbeing of people around the world.

At Smiths Medical, we are passionate about improving and saving the lives of patients through high quality, innovative medical devices and services. We are a leading global manufacturer of specialty medical devices that provides innovative and lifesaving solutions for the world s healthcare markets.

Specializing in Infusion Therapy, Vascular Access, Vital Care, and Specialty Products & Services, our products are found in hospital, emergency, home and specialty care environments and are used during critical and intensive care, surgery, post-operative care and for supporting managing chronic illness.

Smiths Medical is an EEO/AA Employer/Vet/Disabled

If you require assistance with our online job submission process, please contact our Talent Acquisition team at 855-754-5032 to request an accommodation. Additionally, Smiths Medical invites interested deaf and hard of hearing applicants to use Video Relay Service (VRS).

Apply Now