Sr. Compliance Specialist - CAPA
ESSENTIAL DUTIES AND RESPONSIBILITIES To perform this job successfully, an individual must be able to oversee/perform each essential duty satisfactorily. Other duties may be assigned. Management of Document Control/Quality Records processes and personnel. Management of Internal Audit Program and audit team. Management of central CAPA process, including coordination of CAPA Review Board (CRB). Management of site Training program. Quality Management Review Coordination and preparation. Quality Plan project management to ensure timely completion. Alternate site Quality Management Representative. Leadership role (e.g., Backroom Manager) during site audits/inspections. Other QA/Compliance activities as assigned by QA Site Leader. Qualifications DESIRED MINIMUM QUALIFICATIONS The requirements listed below are representative of the knowledge, skill, and/or ability required for this position. Education &
Experience:
Bachelor's degree in Quality Assurance or related discipline or 5-7 years' experience in QA/Compliance within the Medical Device Industry. Extensive experience with development and implementation of QMS. Expert knowledge of medical device regulations (including FDA QSRs, ISO13485). Experience with FDA and/or Notified Body audits/inspections. Experience with Document Control and Records Control processes. Experience with CAPA processes including investigational techniques. Experience with Training program development/implementation. Experience conducting QMS/Quality training. Experience with coordination of Quality Management Reviews. Audit Experience, Auditor certification preferred. Demonstrated experience in successfully leading a team. Ability to interface with top organizational leadership in an effective manner. Ability to communicate effectively (both written and oral) using English (or local language). Demonstrated ability to work cross-functionally in a team environment. Ability to work independently with little supervision. Familiar with the MS Office Suite, including Microsoft Visio and Project. Must be able to observe company policies and safety procedures at all times. Must be able to treat others with respect; work with integrity and ethically; uphold organizational values.
Salary Range:
$80K -- $100K
Minimum Qualification
Auditing & ComplianceEstimated Salary: $20 to $28 per hour based on qualifications.
Experience:
Bachelor's degree in Quality Assurance or related discipline or 5-7 years' experience in QA/Compliance within the Medical Device Industry. Extensive experience with development and implementation of QMS. Expert knowledge of medical device regulations (including FDA QSRs, ISO13485). Experience with FDA and/or Notified Body audits/inspections. Experience with Document Control and Records Control processes. Experience with CAPA processes including investigational techniques. Experience with Training program development/implementation. Experience conducting QMS/Quality training. Experience with coordination of Quality Management Reviews. Audit Experience, Auditor certification preferred. Demonstrated experience in successfully leading a team. Ability to interface with top organizational leadership in an effective manner. Ability to communicate effectively (both written and oral) using English (or local language). Demonstrated ability to work cross-functionally in a team environment. Ability to work independently with little supervision. Familiar with the MS Office Suite, including Microsoft Visio and Project. Must be able to observe company policies and safety procedures at all times. Must be able to treat others with respect; work with integrity and ethically; uphold organizational values.
Salary Range:
$80K -- $100K
Minimum Qualification
Auditing & ComplianceEstimated Salary: $20 to $28 per hour based on qualifications.
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