Purpose

Supervise the team of technicians in the Complaint Analysis Laboratory (DAL). Organize and direct the work of DAL technicians. Provide feedback to Product Surveillance regarding market complaint issues. Ensure the technicians' work maintains consistency and proper coding in product analysis findings.

Key responsibilities

• Manage the performance and planned results regarding DAL activities: Lead time, backlog reduction and control, quality of analysis.
• Attend to and respond to requests from internal/external DAL customers: Product Surveillance, Complaint Analysis Engineer (Further Investigation), Manufacturing, etc.
• Address employee development needs through planning and coaching.
• Communicate and control work goals and expectations, provide support in problem-solving and attending to needs.
• Lead and support continuous improvement initiatives related to DAL processes: Value Stream Map, Business Alignment Projects, etc.
• Ensure regulatory compliance of activities performed in DAL: Applicable standards, norms, and regulations.
• Investigate deviations and implement appropriate corrective actions to eliminate root causes (CAPAs).
• Support further investigations.
• Prepare the area budget and ensure its proper execution. (Recurrent)

Additional responsibilities

• Ensure compliance with corporate and legal EHS requirements by following policies and procedures; ensure compliance by adopting strategies, internal controls, communication, and necessary training.
• Continuously improve EHS results through leadership, commitment and active participation in all EHS initiatives.
• Foster team motivation ensuring that behaviors that promote Abb Vie’s culture are recognized formally and informally, in a timely manner.

Education & Experience

• Bachelor’s in Industrial Engineering, Industrial Production, Chemistry, Biotechnology or a career related to engineering or administration.
• Licentiate in Industrial Engineering or similar (desirable).
• Minimum three years’ experience in quality in process or manufacturing in the medical industry.

Technical Skills

• Problem-solving using Lean tools such as PDCA, A3, DMAIC, Value Stream Mapping, etc.
• Experience in Lean Manufacturing.
• Knowledge of FDA’s Quality System Regulations 21 CFR Part 820; ISO 13485; Council Directive 93/42/EEC; Canadian Medical Device Regulations.

Other requirements

• Knowledge of Good Laboratory Practices and biohazard product handling.
• Intermediate English: able to hold conversations, present industry issues, and write technical documents (procedures, specifications).B2+
• Computer skills: Microsoft Office (Word, Excel, PowerPoint, Visio). Desirable: SAP, Minitab, CPR-Trackwise.
• Special training: knowledge of cycle time, line balancing, capacity, and other Lean Manufacturing concepts.

At Abb Vie, 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. That’s 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 family’s 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 company's 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.

Abb Vie 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

About Abb Vie

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.