Intertek Job - 31714129 | CareerArc
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Company: Intertek
Location: United States of America
Career Level: Entry Level
Industries: Business Services, Consulting

Description

Intertek is a leading Total Quality Assurance provider to industries worldwide.  Our network of more than 1,000 laboratories and offices with over 43,000 people in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection, and Certification solutions for our customers' operations and supply chains.  Intertek Total Quality Assurance expertise, delivered consistently with precision, pace, and passion, enables our customers to power ahead safely.     

 

The Business Assurance group of Intertek provides a full range of business process audit and support services, including management systems certification, custom supplier audits, and training. Our range of services helps to ensure customer management systems are optimized to facilitate successful growth.


Overview:


  • The ideal candidate will lead and/or participate in the assessment of client technical documentation to determine compliance with relevant EU regulations (MDD, MDR). 
  • The ideal candidate will conduct audits and develop other TD assessors.
  • This will be a remote/home-based full-time position.   
  • As required, audit client management systems as lead auditor or team member for compliance with established standards, client, and/or industry requirements, government regulations, and other relevant standards, specifically ISO 13485, MDSAP, MDD and MDR, and other requirements related to the medical device industry sector, including planning, reporting, and post-audit activities.
  • As required, train/mentor/coach other personnel to perform TD assessment, including determining competence, performing training, providing feedback, reviewing assessment reports, liaising with NB competence and training personnel, etc.
  • Maintain accurate and current training and assessment history records as part of ongoing competency evidence and development.
  • Assist, support, and attend all calibration sessions/assessor conferences, department meetings, and assessor team meetings.
Responsibilities:
  • Perform pre-assessments and conformity assessment of client technical documentation (TD) to the requirements of the EU MDD and MDR, according to processes and procedures, including:
o Document the above assessments and reviews in accordance with the appropriate current local and global Intertek issued processes and complete them in timely manner. o Identify and document non-conformities as necessary. o As part of the conformity assessment and where approved to do so, review conformity of: microbiology and sterilization, biocompatibility and/or clinical data evaluation. o Liaise with the client to address any findings in a timely manner. o Lead and manage the technical assessment team (all assessors involved in the TD review) when required by the assessment project. o Perform quality checks, peer-review, and/or sign-off of other assessor's assessments prior to submission of report to client. o Correspond generally with clients as needed in respect of the scheduled assessment activity. o Raise suspension documentation as needed where findings are not adequately addressed.
  • Perform reviews of client's Change Notices, making recommendations for Certification Authority personnel on proposed actions.
  • Perform technical assessments of client's vigilance reports and determine next actions, including making certification recommendations.
  • As required, audit client management systems as lead auditor or team member for compliance with established stand
  • Maintain accurate and current training and assessment history records as part of ongoing competency evidence and development
  • Assist, support, and attend all calibration sessions/assessor conferences, department meetings, and assessor team meetings.


Qualifications

Requirements: 
  • Relevant formal education equivalent to a 4-year college/university degree in the U.S. (biology or microbiology; chemistry or biochemistry; computer and software technology; electrical, electronic, mechanical or bioengineering; human physiology; medicine; pharmacy; physics or biophysics)
  • 3 years of experience in similar roles, e.g. previous experience with Management System registrars and Notified Bodies as qualified third-party auditor and TD assessor. 
  • Experience working in a health science/medical device industry in Design, Manufacturing, or Quality and/or Regulatory functions preferred.
  • Strong communication and interpersonal and time management skills.
  • Sound judgment, organization, and analytical skills.  
  • The ability to manage workload and operate without direct daily supervision.
  • The ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Must be able to take ownership and accountability for delivering results, building trust in relationships and showing respect for others, processing information quickly and identifying the key challenges in complex situations.
  • Must be able to manage multiple tasks and work proactively and in a self-reliant manner.
  • Must have a keen eye for detail and be focused on delivering accurate and robust assessments within agreed time frames.
  • Must operate ethically with a good degree of professional integrity.
  • Excellent computer and writing skills, including MS Office

Travel Requirements:
  • Must be willing and able to travel, including international travel (requires passport).


A career with Intertek means joining a global network of professionals dedicated to bringing quality and safety to life. Our vision is to become the world's most trusted partner for Quality Assurance and we offer our employees the chance to make an impact with attractive growth opportunities in this industry on a global scale.

 

We offer a salary and benefit package competitively placed within the local market, including medical, dental, vision, life, disability, 401(k) with company match, tuition reimbursement and more.

 

We are an Equal Opportunity Employer and do not discriminate against applicants due to veteran status or on the basis of disability.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, or gender identity. 

 

Intertek is a drug-free workplace. As a condition of employment, all hires are required to pass a pre-employment drug test. 


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