Contract Medical Device Lead Auditor

DQS; United States; Remote; USD 110,000 - 165,000; Full time

Job summary

DQS Inc. is seeking a Medical Device Lead Auditor to perform client-site audits on a home-based contract basis with extensive travel across the United States.

You will lead audit teams, develop scopes, and present conclusions to customers while ensuring compliance with ISO 9001/13485 and relevant regulatory requirements. The ideal candidate has a bachelor’s degree in a physical or life science or engineering, at least four years in quality systems management and medical device development, plus

Qualifications

• Bachelor's degree in physical or life sciences or engineering.
• Minimum four years in quality systems management.
• Four+ years in medical device development/manufacture/testing with knowledge of US/Canada/EU regulations and ISO 14971 risk management.
• Passed or able to pass ISO 9001/ISO 13485 Lead Auditor course (40 hours).
• Experience with ISO 13485, MDD and/or CMDCAS is desirable.

Responsibilities

• Knowledge of principles and methods for management systems audits.
• Experience auditing ISO-9001, ISO 13485, and/or GMP.
• Preference for RAB-QSA or Exemplar Global Lead Auditor qualifications.
• Develop audit scope and plan; manage audit team activities.
• Present audit conclusions to customer and resolve nonconformities.
• Assess customer needs and meet UL DQS service standards.
• Work independently and project a professional image.
• Extensive travel.

Skills

Quality systems management experience

Medical device regulatory knowledge (U

Education

Bachelor's degree in physical/life science or engineering

ISO 9001/ISO 13485 Lead Auditor course (40-hour)

ISO 13485, MDD/CMDCAS knowledge

Job description

Your role

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 Responsibilities

• 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

DQS Inc. is an Equal Opportunity Employer. Minorities/Women/Veterans/Disabled

EQUAL EMPLOYMENT OPPORTUNITY (EEO)

Qualified applicants are considered for employment without regard to race, religion, sex, national origin, age, marital status, sexual orientation, veteran status, disability, or other protected characteristic.

The employer is subject to certain governmental recordkeeping and reporting requirements for the administration of civil rights laws and regulations. In order to comply with these laws, the employer invites employees to voluntarily self-identify their race or ethnicity. Submission of this information is voluntary and refusal to provide it will not subject you to any adverse treatment. The information obtained will be kept confidential and may only be used in accordance with the provisions of applicable laws, executive orders, and regulations, including those that require the information to be summarized and reported to the federal government for civil rights enforcement. When reported, data will not identify any specific individual.

Right to Work Poster (English)

Right to Work Poster (English)