Medical Device QMS Auditor- New Jersey
Company: The British Standards Institution (BSI)
Location: Jersey City
Posted on: November 14, 2023
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Job Description:
Great that you're thinking about a career with BSI! 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 $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 #LI-MS1 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.
Keywords: The British Standards Institution (BSI), Jersey City , Medical Device QMS Auditor- New Jersey, Accounting, Auditing , Jersey City, New Jersey
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