Medical Device QMS Auditor at BSI Group America

Las Vegas, Nevada, United States -

Full Time

Start Date

Immediate

Expiry Date

21 Mar, 26

Salary

123860.0

Posted On

21 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management Systems, ISO 13485, CE Marking, MDSAP, Assessment Reports, Client Communication, Team Leadership, Coaching, Time Management, Public Speaking, Business Development, Analytical Skills, Attention to Detail, Self-Motivation, Flexibility, Pressure Management

Industry

Professional Services

Description

We exist to create positive change for people and the planet. Join us and make a difference too! Do you believe the world deserves excellence? BSI (British Standards Institution) is the global business standards company that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence. Our Medical Devices (or Regulatory Services) team ensures patient safety while supporting timely market access for our clients' medical device products globally. BSI is an accredited ISO 13485 Certification Body recognized in many global markets Essential Responsibilities: Analyze quality systems and assess ISO 13485, CE Marking and MDSAP schemes. Prepare assessment reports and deliver findings to clients to ensure client understanding of the assessment decision and clear direction to particular items of corrective action where appropriate Recommend the issue, re-issue or withdrawal of certificates, and report recommendations in accordance with BSI policy, procedures and prescribed time frame. Maintain overall account responsibility and accountability for nominated accounts to ensure an effective partnership, whilst ensuring excellent service delivery and account growth. Lead assessment teams as required ensuring that team members are adequately briefed so that quality of service is maintained and that effective working relationships are sustained both with Clients and within the team. Provide accurate and prompt information to support services, working closely with them to ensure that client records are up to date and complete and that all other internal information requirements are met. Coach colleagues as appropriate especially where those members are inexperienced assessors or unfamiliar with clients' business/technology and assist in the induction and coaching of new colleagues as requested Plan/schedule workloads to make best use of own time and maximize revenue-earning activity. Education/Qualifications: Associate's degree or higher in Engineering, Science or related degree required Minimum of 4 years experience in the medical device field including at least 2 years must be hands-on medical device design, manufacturing, testing or clinical evaluation experience. The candidate will develop familiarity with BSI systems and processes as they go through the qualification process. Knowledge of business processes and application of quality management standards. Good verbal and written communication skills and an eye for detail. Be self-motivated, flexible, and have excellent time management/planning skills. Can work under pressure. Willing to travel on business intensively. An enthusiastic and committed team player. Good public speaking and business development skill will be considered advantageous. The salary for this position can range from $98,100 to $123,860 annually; actual compensation is based on various factors, including but not limited to, the candidate’s competencies, level of experience, education, location, divisional budget and internal peer compensation comparisons. BSI offers a competitive salary, group-sponsored health and dental, short-term and long-term disability, a company-matched 401k plan, company paid life insurance, 11 paid holidays and 4 weeks paid time off. #LI-REMOTE #LI-MS1 About Us BSI is a business improvement and standards company and for over a century BSI has been recognized for having a positive impact on organizations and society, building trust and enhancing lives. Today BSI partners with more than 77,500 clients in 195 countries and engages with a 15,000 strong global community of experts, industry and consumer groups, organizations and governments. Utilizing its extensive expertise in key industry sectors - including automotive, aerospace, built environment, food and retail, and healthcare - BSI delivers on its purpose by helping its clients fulfil theirs. Living by our core values of Client-Centricity, Agility, and Collaboration, BSI provides organizations with the confidence to grow by partnering with them to tackle society’s critical issues – from climate change to building trust in digital transformation and everything in between - to accelerate progress towards a better society and a sustainable world. BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace. Not found an opportunity of interest currently listed? Introduce yourself to the BSI TA team, set up personalized jobs alerts and easily apply for future opportunities. At BSI, we exist to have a positive impact. Our people influence international thinking and action on important issues. Their work builds trust in businesses and communities and enhances lives. Now we’re looking for passionate people to help us take on society’s biggest challenges. You’ll partner with key stakeholders to accelerate progress towards a better society and a sustainable world. Together, we’ll create solutions to global challenges like the climate crisis and how AI will be used. You’ll do rewarding, purpose-led work that impacts people’s health, safety and wellbeing. Your integrity will earn the trust of our stakeholders as we raise awareness of the difference we make to people around the world. You’ll have the opportunity to work across a wide range of industries across the globe. Are you looking to grow your career in an organization that supports your development and performance? You can be your best self, do your best work and make a difference here, because life at BSI is #NotYourStandardCareer. Be part of our future.

How To Apply:

Incase you would like to apply to this job directly from the source, please click here

Responsibilities

The Medical Device QMS Auditor will analyze quality systems and assess compliance with ISO 13485, CE Marking, and MDSAP schemes. They will prepare assessment reports, deliver findings to clients, and maintain overall account responsibility for effective service delivery.