Are you passionate about ensuring top-notch quality and continuous improvement? Join our dynamic team and be at the forefront of delivering excellence! We have three (3) Senior Improver, Global Quality Engineering openings in our Global Quality Team. Become a key player in maintaining and enhancing the quality of our products, processes, new product introduction and capacity increase projects. Positions work onsite in our Juana Diaz, Puerto Rico campus.

The Senior Quality Improver acts as the functional representative and enables the implementation and execution of projects and initiatives to enhance Quality Systems and workflows with a variety of stakeholders (Manufacturing, R& D, Packaging, GTIG, and Distribution Centers, among others). Performs and/or coordinates specific tasks and functions within the company's Quality System such as new product introduction, capacity increase projects, innovation center and overall growth driven project support while identifying and implementing corrective and preventive actions assuring compliance.

Essential Functions & Accountabilities:

• Performs and supports technology, new product introduction and/or product transfers through strong collaboration with R& D, QA, GTIG (Global Technical Innovation Team), PTIG (Packaging Technical Innovation Team), and manufacturing facilities.
• Acts as the Quality representative on cross-functional teams, driving and advancing quality improvement projects and process/product characterizations to drive continuous improvement and cost efficiency.
• Support the deployment of quality engineering methodologies and product evaluation techniques across the organization.
• Proactively identify and address potential quality issues. Foster a culture of quality awareness throughout the organization.
• Analyze quality issue reports from manufacturing and QA. Analyze documentations including validation plans, reports, quality plans, control plans and pFMEAs among other documents.
• Gather data and investigate quality issues to determine root causes and align on applicable action plans.
• Develop and implement corrective and preventive actions. Prepare comprehensive reports for Corrective and Preventive Actions (CAPA).
• Create protocols and memos for Non-Conformance Reports (NCRs).
• Assess and evaluates effectiveness and resolution of NCRs.
• Lead investigations, address NCRs, quality feedback, and customer complaints. Investigate and resolve quality system issues
• Track, monitor and measure quality related key performance indicators (KPIs).
• Keeps business units updated on current quality KPIs.
• Create actions to enhance quality KPIs.
• Track and monitor incidents and acceptance data for continuous improvement.
• Drive improvement initiatives across the organization.
• Developing and create documentation supporting Quality improvements.
• Creates, develops and refines procedures.
• Other duties as assigned.

Qualifications, Knowledge, Skills and Abilities Required:

• Expertise in implementing Quality Engineering practices ensuring compliance with design control, validations, sampling plans, and risk management.
• Excellent verbal and written communication skills in English and Spanish. Advanced proficiency in conveying complex information and facilitating the adoption of new tools and improvements.
• Decision making and results drive. Adept in evaluating initiatives, identifying problems, and making timely decisions.
• Ability to build and leverage networks to support quality initiatives.
• Interpersonal Skills: Effective in building relationships at all organizational levels. Efficient in managing workloads and meeting deadlines.
• Data Analysis & Report Writing Skills: Proficient in analyzing data and producing clear, actionable reports. Robust technical writing ability.
• Business Awareness: Understanding of customer needs and alignment with business goals.
• Strong problem-solving skills with expertise in critical thinking, data analysis, and risk management using a variety of tools and techniques.
• Competency in Electronic Quality Management Systems and relevant IT tools.

Experience:

• Five (5) years of quality engineering / quality systems experience in in the regulated manufacturing industry required.
• Medical device (med-tech) experience required.
• Proficient in CGMP, MDSAP, and ISO 13485 regulated environments.
• Strong practical knowledge of statistical tools: DOE, acceptance sampling, SPC, Design Control, among others required.
• Knowledge and/or exposure in the vision care / optics field highly desirable.
• Exposure and experience in a global or matrixed organization strongly preferred.
• Available to travel ten percent (10%) of the time.

Education:

• Bachelor's degree in science, engineering or related technical field required.
• Advanced (graduate degree such as MBA, MS, PhD), and/or professional certifications preferred.

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