Medical Devices QMS Assessor

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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.

Overview

This role is to act as a ISO / 13845 Quality Assurance Auditor. The individual will be responsible for delivering BSI’s audit services to assigned clients in accordance with all BSI, scheme and regulatory requirements to assure timely, cost-effective service delivery that assures satisfaction of our customer needs.

The candidate must be located on the West Coast of the United States and be willing to travel at a minimum of 60-80% of the time

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 :

• Bachelor’s degree in Biology or related subject (Biomedical Sciences, Biochemistry, Biological Sciences, Molecular Biology, Immunology, Biochemistry, microbiology etc.)
• Minimum of 4 years experience in medical device field including at least 2 years must be hands-on medical device design, manufacturing, testing or clinical evaluation experience.
• Must have experience in one or more of the following : Devices : e.g. wound dressings, absorbable / non-absorbable meshes, heart valves, bone substitutes, hemostats, shoes, grafts etc.

Materials (animal e.g. bovine, porcine, ovine, etc.) : collagen (hide, tendon, bone, fish scales), heart valves, gelatin, heparin, tallow derivatives (oleates, stearates, glycerol etc.

fetal calf serum, enzymes, culture media, hyaluronic acid (bacteria, combs), leather, chitosan etc.Materials (human) : cornea, heart valves, allograft tendons, cartilage etc.

• 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., this is not a home-office or remote position, it is a field based position.
• An enthusiastic and committed team player.
• Good public speaking and business development skill will be considered advantageous.

What we offer :

The salary for this position can range from $90,100 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

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Our Excellence Behaviours : Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI.

They help us ensure that BSI is a great place to work and a highly successful business.

BSI is an Equal Opportunity Employer and we are committed to diversity.

BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.