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As the Associate Quality Manager for a medical device manufacturer, this position is primarily responsible for assuring compliance to all regulatory requirements. This position will support Quality operations for Latin America (Brazil, Colombia, Argentina, Mexico, Peru, Chile) and will have responsibility for the following: CAPA, NCs, audits, recalls and complaints at a minimum.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Fulfill the responsibilities of the Technical Responsible Person for Brazil and other required quality roles per LATAM (Colombia, Argentina, Mexico, Peru, Chile) regulations. This includes maintaining QMS for Brazil.
- Work in partnership with the LATAM 3rd party distributors to ensure all activities and operations are carried out in compliance with local, state, federal, and international regulations and laws governing the quality operations. This includes management of Distributor Quality Agreements for LATAM.
- Oversee reporting activities (complaints and field safety corrective actions) to ANVISA and LATAM (Colombia, Argentina, Mexico, Peru, Chile) market authorities.
- Responsible for leading all site QA audits, including hosting auditors onsite as required as well as responding to all audit/documentation requests.
- Other Duties as assigned
MINIMUM QUALIFICATIONS/REQUIREMENTS
- Education: Bachelor’s degree in a scientific, engineering, or equivalent discipline 8+ years of experience or equivalent education and years of experience or Master degree with 5+ years of experience or equivalent education and years of experience
- Current registration with the Regional Professional Council in São Paulo – Brazil
- ASQ Certification as a CQA desired
- Fluent in Portuguese, Spanish, and English for both written and verbal communications
- Must live in Brazil
Experience:
- Prior experience with Medical Devices and Instruments is required.
- Strong analytical skills, exceptional writing, and interpersonal relationship skills
- Fully competent in all conventional aspects of the subject matter, functional area, and assignments.
- Compiles and analyzes data, identifies causes, draws conclusions, generates reports.
- Uses expertise to improve operational efficiencies and meet compliance requirements.
- Strong statistical analysis skills.
- Strong working knowledge Microsoft Office programs (Word, Excel, Access, PowerPoint).
- Experience working in Oracle, Agile and TrackWise systems preferred.
- Maintain and improve the local Quality Management System in accordance with Brazilian and international standards.
- Partners with corporate quality and regulatory teams to ensure global alignment of qualities policies, procedures and agreement.
- Conduct internal and external audits to ensure compliance with Quality Standards (ANVISA, INMETRO, MDSAP, ISO 13485) .
- Manage tracking, reportability, and closure of complaints, nonconformities (NCs), Corrective/Preventive Actions (CAPAs) and Recalls reporting within a timely manner in accordance with internal procedures and external requirements.
- Support global NCs and CAPAs to resolve quality issues which impact Latam markets.
- Ensure proper documentation and record keeping for quality processes, both at the Brazilian site and with any 3rd party logistics providers in Latin America.
- Organize and run Brazilian Management Review meetings.
- Provide training to local staff and distributors on quality standards.
- Host for any audits that may need to take place at the Brazilian site and support international team as needed.
- Ensure that all quality activities comply with the requirements of all applicable laws and are fully consistent with approved labeling and all applicable product authorizations.
Unsolicited Agency Submission
Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.
