Manager, Quality Control

Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

Our location in San Diego, CA currently has an opportunity for a Manager, Quality Control within our CMI business unit. 

WHAT YOU’LL DO

This role is responsible for implementing and maintaining the Quality Improvement tools, more specifically, the CAPA and Nonconformance systems.  Must work well with others in the organization to ensure the above listed processes are compliant to internal and external requirements.

RESPONSIBILITIES:

• Ensure processes and procedures are in alignment with FDA and ISO requirements as well as ARDx global policies.
• Interprets and executes policies that affect work processes and personnel within the assigned organizational unit.
• Translates department goals into individual objectives and KRAs.
• Monitors daily work operations and provides direction and guidance to, experienced exempt employees, or skilled nonexempt staff to achieve unit or project goals.
• Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.
• Manages overall health of owned systems including staffing towards department and Company goals, including hiring, feedback on performance, employee development, appraisals, and disciplinary actions, etc.
• Ensures sustaining support of Quality System and regulatory compliance by individually working quality system issues and by delegating project work for maintaining quality system capability.
• Directs Quality personnel to support new product development by defining projects focused on new products/process development based on coordination with management, project leaders, & design engineers.
• Implements improvements to Quality Systems and tools by directing personnel to gather data on existing quality tools, identify weaknesses, and research/select new tools based on findings.
• Provides manufacturing support by defining work assignments directed to address manufacturing process defects and implement process improvements utilizing Quality System tools.
• Monitors departmental activities and records to ensure compliance independent action through critical decision making.
• Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources.
• Manages performance of staff towards department and Company goals, including feedback on performance, appraisals, recommendations for merit increases or necessary disciplinary actions, communication to employees on performance, etc.
• Demonstrates commitment to the development, implementation and effectiveness of Abbott Quality Management System per ISO, FDA, and other regulatory agencies.
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; build productive internal/external working relationships.
• Carries out duties in compliance with established business policies.
• Other duties as assigned, according to the changing needs of the business.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

• BS/BA degree in a science related or technical field or equivalent combination of education and work experience.
• Minimum of seven years related experience working in a professional environment where compliance was of vital importance and management experience.
• Minimum 5 years’ experience in a lead or supervisory position.
• Working knowledge of Quality Assurance in a medical device manufacturing environment, preferably in-vitro diagnostic.
• Knowledge of Quality System Regulations and/or ISO 13485.
• Holds others accountable by focusing on the right metrics, tracking results and creating transparent reviews.
• Excellent organization skills — must be able to manage a large number of simultaneous projects. 
• Attention to detail — must have precision in work completed, especially as it relates to understanding and documenting complex quality issues.
• Excellent writing skills — must be able to summarize complex issues in a clear, succinct and accurate manner. Must be able to write in a manner that effectively conveys complex issues to the reader.
• Strong communication, problem solving and motivational skills.

PREFERRED QUALIFICATIONS:

• Six Sigma green or black belt certification.
• Strong management skills with proven leadership and team building skills.
• Motivates the team by understanding unique needs and engages in frequent conversations and performance coaching.
• Attracts, selects, develops and manages talent for higher levels of performance.
• Assesses issues thoroughly and solves complex problems; removes roadblocks for the team.
• Demonstrated ability to carry out assignments in a timely, accurate manner and accomplishing tasks as required with little or no supervision.
• Ability to interact effectively with all levels of the organization, engage resources and perform multiple tasks in a fast-paced environment. 

COMPETENCIES:

• Initiative
• Teamwork
• Communication
• Problem solving

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please contact your local HR department.

The base pay for this position is $109,300.00 – $218,500.00. In specific locations, the pay range may vary from the range posted.

• quality management
• process development
• capa
• medical device manufacturing
• quality management implementation
• manufacturing support
• quality improvement
• operational monitoring
• leadership development
• regulatory compliance
• task management
• product design
• project coordination
• quality system regulations
• product development
• quality improvement implementation
• goal translation
• performance management
• staffing planning
• policy compliance
• kras
• quality control awareness
• quality assurance
• quality system compliance
• compliance monitoring
• professional relationship building
• policy execution