MAIN PURPOSE OF ROLE
Be a quality professional who applies compliance criteria, scientific knowledge, engineering knowledge, statistical, and ingenuity to complete or lead assignments related to a specific technical field or discipline.
Provide direction and leadership to Manufacturing Quality Assurance, Manufacturing Quality Improvement and Compliance culture.
Provide Quality support to manufacturing, helping to ensure delivery of the highest quality product to the customer. Provide support to Development / Improvement teams for new or existing products.
Ensure that activities are performed and documented per systems and procedure in accordance with Abbott Policies and applicable Quality And Regulatory Requirements.
Able to supervise personnel successfully.
Apply quality principles, analyzes quality records, prepares reports and recommends improvements.
Conduct verification and validation of components or materials used in development processes.
Identify and address recurring problems either with the quality of the product or the reliability of testing procedures.
Document quality issues and performance metrics for review boards.
Interfaces with internal company contacts and external network.
Plans and conducts high level assigned projects within quality specialty requiring conventional types of plans, investigations, and / or equipment.
prepares for such eventualities.
Independently investigates, conducts tests or experiments, gathers data, and performs preliminary analysis. Reports findings.
Prepares and communicates recommendations and respective action plans.
Predicts patterns / trends. Grasps complexities and sees relationships among data; determines consequences and alternatives; makes recommendations.
Mentors others by sharing technical expertise and providing feedback and guidance.
Builds relationships. Initiates and cultivates open, honest relationships with colleagues, customers, contractors, and vendors by establishing rapport, developing an understanding of others’ needs, promoting common goals, and following through on commitments.
Identifies and evaluates areas of risk with respect to compliance, Product / Mfg performance, develops procedures, maintain FMEAs.
Resolves problems and provide guidance, such as production process deviations, non-conformances (CAPA), field product performance, urgent out-of-stock replacements, and crisis situations requiring fast, astute decisions with rapid implementation by utilizing technical training and experience.
Bachelor’s Degree in Engineering, science or closely related discipline is desired.
3-5 years of experience in medical device or related industries.
Fully Bilingual (English and Spanish) / Required
Preferred Qualifications & Education
FDA / ISO regulation knowledge.
CQE / CQA / Lean / Six Sigma certification is desired.
Personal skills needed include Leadership, accountability, tact, open-mindedness, maturity, tenacity, decisiveness, self / reliance, scientific thinking, diligency, resourcefulness, customer focus.
Capable to persuade and motivate others to improve quality.
Effective communication skills.