Medical Device QMS Auditor

Position Overview

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.

Key Responsibilities

• Analyze quality systems and assess ISO 13485, CE Marking and MDSAP schemes.
• Prepare assessment reports and deliver findings to clients to ensure clear understanding of the assessment decision and guidance on corrective actions.
• Recommend the issuance, re-issuance, or withdrawal of certificates in accordance with BSI policy, procedures, and timelines.
• Maintain account responsibility for nominated accounts to ensure effective partnerships, excellent service delivery, and account growth.
• Lead assessment teams by briefing team members to maintain high service quality and foster effective working relationships with clients and within the team.
• Provide accurate, prompt information to support services to ensure client records and internal information requirements are up to date.
• Coach colleagues, especially less experienced assessors, and assist in the induction and training of new team members when requested.
• Plan and schedule workloads to optimize time usage and maximize revenue-earning activities.

Required Qualifications

• Education: Associate's degree or higher in Engineering, Science, or a related field.
• Experience Required: Minimum of 4 years in the medical device field, including at least 2 years in design, manufacturing, testing, or clinical evaluation.
• Qualifications: Familiarity with BSI systems and processes along with knowledge of quality management standards; excellent verbal and written communication and strong attention to detail.
• Requirements: Ability to work under pressure, a willingness to travel extensively, and proven time management and planning skills, complemented by a committed team-player attitude.

Preferred Qualifications

• Qualifications: Good public speaking and business development skills will be considered advantageous.

Benefits & Perks

• Salary: $98,100 to $123,860 annually; actual compensation is based on various factors including competencies, level of experience, education, location, divisional budget, and internal peer comparisons.
• Benefits: 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.