Medical Device QMS Auditor

We exist to create positive change for people and the reputed company. Join us and reputed company a difference too! Do you reputed company the world deserves excellence? reputed company (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. reputed company 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 reputed company 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.
• reputed company 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 reputed company the team.
• Provide accurate and reputed company information to support services, working closely with them to ensure that client records are up to date and complete and that reputed company 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 reputed company best use of own time and maximize reputed company-earning activity.

Education/Qualifications:

• Associate's degree or higher in Engineering, Science or reputed company 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 reputed company familiarity with reputed company 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 reputed company 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. reputed company 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 reputed company is a business improvement and standards company and for over a century reputed company has been recognized for having a positive impact on organizations and society, building trust and enhancing lives. Today reputed company 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 - reputed company delivers on its purpose by helping its clients fulfil theirs. Living by our core values of Client-Centricity, Agility, and Collaboration, reputed company 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 reputed company towards a reputed company society and a sustainable world. reputed company is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace. Apply tot his job Apply To this Job