Contract Medical Device Lead Auditor

DQS South Africa (Pty) Ltd.; Schaumburg, Northern (IL, KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

DQS Inc. is seeking a Medical Device Lead Auditor to conduct audits at client locations under an assigned schedule.

The role combines remote coordination with extensive travel to assess compliance with ISO 9001, ISO 13485, and GMP standards for medical devices. Candidates should have a bachelor’s degree in a science or engineering field and at least four years of quality systems and medical device experience, plus lead auditor certification.

Qualifications

• Bachelor’s degree in a physical or life science or engineering.
• Minimum of four years experience in quality systems management.
• Minimum of four years experience in medical device development, manufacture and/or testing with regulatory knowledge in US, Canada and EU.
• Passed or able to pass a 40-hour ISO 9001 or ISO 13485 lead auditor course.
• Experience implementing ISO 13485, MDD and/or CMDCAS desired.

Responsibilities

• Knowledge of principles and methods for management systems audits.
• Perform audits at client locations per schedule.
• Develop an audit scope and audit plan and manage audit team activities.
• Present audit conclusions to the customer and review nonconformity resolutions.
• Assess customer needs and meet UL DQS service and customer satisfaction standards.
• Work independently and project a professional image; extensive travel.

Skills

Auditing principles

ISO 9001/13485 auditing

Lead auditor experience

Audit planning

Customer communications

Independent work

Travel readiness

Education

Bachelor’s degree in science or engineering

Job description

**Your role****Medical Device Lead Auditor** DQS Inc. has an immediate contract opportunity for a Medical Device Lead Auditor. Working closely with your schedulers, you will visit client locations and perform the audits as specified. Position is home based with extensive travel. Job Responsibility:* Knowledge of principles and methods for management systems audits.* Experience with internal, 2nd or 3rd party ISO-9001, ISO 13485, and/ or GMP auditing.* Preference given to RAB-QSA or Exemplar Global Lead Auditor or Auditor qualification.* Ability to develop an audit scope and audit plan and manage audit team activities.* Ability to present the audit team conclusions to the customer and review customer resolution of any nonconformities.* Must be able to assess customer needs and meet UL DQS service and customer satisfaction standards.* Work independently and project a professional image appropriate to the work environment.* Extensive travel.**Your profile*** Bachelor’s degree in a physical or life science or electrical, mechanical or biotechnology engineering required* Minimum of four years experience in quality systems management.* Minimum of four years experience in medical device development, manufacture and/or testing, with demonstrated knowledge of US, Canada and EU medical device regulatory requirements, experience with device submittals and knowledge of risk management principles such as ISO 14971.* Passed or ability to pass an accredited 40-hour ISO 9001 or ISO 13485 lead auditor course.* Experience in implementation of ISO 13485, MDD and/ or CMDCAS desired.EEO is the Law Right to Work Poster (English) DQS Inc. is an Equal Opportunity Employer. Minorities/Women/Veterans/Disabled