Quality Complaint Specialist
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Job Location:
Heredia - Costa Rica
Monthly Salary:
Not Disclosed
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
General Purpose: Responsible for providing support and executing investigations for complaints regarding medical or pharmaceutical products. Manages documents and reports quality events while contributing to regulatory compliance continuous improvement and service excellence collaborating with internal and external teams and fostering an inclusive environment.
Main Responsibilities:
- Investigate analyze and follow up on product complaints performing functional visual or dimensional testing as needed.
- Document all relevant information (product history device records risk documentation labeling) ensuring compliance with good laboratory manufacturing and documentation practices.
- Determine root cause of complaints and conduct basic statistical analysis reporting results to teams.
- Identify potentially reportable events and escalate as appropriate (to PMS Manager Clinical Specialist regulatory authorities).
- Support the management of CAPAs NCEPs OOTs and other improvement and compliance activities.
- Participate in continuous improvement and innovation projects related to complaint investigation processes.
- Use documentation systems (QMS databases tracking sheets) to monitor track and report results.
- Train peers in processes/products when required.
- Collaborate with product integration and transfers from/to other sites.
- Assist in environmental health and safety (EHS) ensuring proper calibration preventive maintenance and control of laboratory equipment.
- Manage complaint investigations closure effectively and promptly.
- Support communication with third parties (OEMs Contract Manufacturers internal clients functional areas).
Qualifications :
Formal requirements:
- University degree (engineering science technology health) or equivalent experience.
- 2 years of experience in similar positions (regulated industry medical devices laboratory quality).
- Knowledge of FDA regulations ISO 13485/14947 EU MDD/MDR good laboratory and manufacturing practices and risk analysis tools (FMEA FTA).
- Skills in technical documentation data analysis basic statistics problem solving and effective communication.
- Experience with complaint management and documentation systems (QMS databases spreadsheets).
- Intermediate to advanced English (B2)
Soft Skills:
- Results-oriented planning organizational agility.
- Active listening decision making and problem solving.
- Ability to collaborate with cross-functional teams and manage multiple priorities.
- Commitment to diversity equity and inclusion and corporate policies.
Added Values:
- Customer-oriented and focused on service excellence.
- Active participation in continuous improvement innovation and compliance initiatives.
- Compliance with legal corporate EHS standards and internal diversity and equality policies.
Additional Information :
At AbbVie we are committed to cultivating a workplace culture that promotes inclusion diversity and personal growth. We recognize that our collective success is based on the individual well-being of our employees which is why we have designed a benefits package that considers every aspect of their lives.
- Enhanced Health and Wellness Coverage: Our administrative staff enjoys comprehensive medical and dental insurance ensuring peace of mind for you and your loved ones.
- Extended Vacation: We believe in the balance between work and personal life for our administrative team. Thats why we offer additional vacation days beyond legal requirements.
- Flexible Hybrid Work Model: For eligible positions within our administrative staff we have adopted a hybrid work scheme allowing the convenience of working from home two days a week.
- Life Insurance: Secure your familys future with our life insurance policy.
- Employee Assistance Program (EAP): Access professional support with our comprehensive EAP offering psychological legal and financial counseling.
- On-Site Health Services: Benefit from the convenience of having a company doctor and physical therapy services demonstrating our commitment to your health and well-being.
- Community and Social Engagement: Make a difference with a paid volunteer day allowing you to contribute to the community during company working hours.
- Special Leave Benefits: Celebrate your life achievements with extra leave days for marriage and enjoy your birthday with a day off.
- Employee Stock Purchase Plan: Participate in our companys success by purchasing shares at a special price exclusive to employees.
- Transportation and Meals subsidized.
- Solidary Association: Join a community focused on mutual help and enjoy the benefits that come with being a member.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
- Quality Assurance
- FDA Regulations
- Data Collection
- Food Safety Experience
- ISO 9001
- Mobile Devices
- Root cause Analysis
- Quality Systems
- OSHA
- Food Processing
- Quality Management
- cGMP
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
