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Compliance Auditor III

3 months ago

Temecula, United States Volt Full time
We bring you Tomorrow's opportunity, today.

Volt is immediately hiring a Compliance Auditor in TEMECULA, California 92591

As a Compliance Auditor, you will be.

  • Have a technical background, be familiar with applicable US and foreign regulations, standards, corporate and divisional standards.
  • Specifically, the individual must have a working knowledge of Quality Systems Regulations (QSR) and International Standards (ISO13485).
  • Additionally, the individual must understand a variety of quality/operational systems that support facility, product design, development, production, distribution, installation, and understand the principals of quality management.
  • Bachelor's degree (in Engineering preferred) or equivalent experience and sufficient exposure to pharmaceutical or medical device related industries required along with 4+ years relevant experience as Internal Auditor, Quality Engineer and/or Manufacturing Engineer in an R & D and /or manufacturing environment in pharmaceutical or medical device related industries.
  • Position requires significant product and systems related knowledge.
  • Excellent oral and written communication skills.
  • Perform quality system and manufacturing process audits.
  • Prepare audit report that establishes the outcome of the audit and the detail of non-conformances identified during the audits.
  • Track audit results including corrective actions and follow up to these actions as required.
  • Support Client Third party and regulatory agency inspection as required.
  • Provide support to SQA team as needed.
Key Responsibilities:
  • Related work experience with a strong understanding of audit process per ISO 13485 and FDA regulations for Medical Device
  • A minimum of 6 years working in Medical Device Industry
  • Good problem-solving skills and critical thinking
  • Demonstrate excellent interpersonal skills when dealing with internal and external customers.
  • Demonstrate fact-based decision-making skill.
  • Communicate effectively both written and oral modes.
  • Ability to work independently and effectively with other team members.
  • Bachelor's degree - prefer in Science or Engineering.
  • CQA (preferred).

Location: TEMECULA, California 92591

Duration: 13+ Months contract

Pay:?$38-40/hr

Shift Timing- 1st shift.

*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Qualified candidates should?APPLY NOW?for immediate consideration Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.

Benefits:?Volt offers benefits (based on eligibility) that include the following: health, dental, vision, term life, short term disability, AD&D, 401(k), Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

Volt?is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Volt is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at?hr_dept@volt.com. ?Please indicate the specifics of the assistance needed.

Volt?does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.?

Job ID : 428157