Responsible for handling investigation of customer complaints and implement Corrective / Preventive Action (CAPA) to prevent re-
occurrence. Resolution of complex Quality issues by means of identification root cause(s). Participate in Quality / Cost improvement projects.
Support of Product / Process validation protocols and verify final summary reports. Trainer in Quality disciplines as required.
Responsible for leading the Quality Continual Improvement efforts to attain Total Customer Satisfaction. Interact with R & D, QA / RA and Technical Support personnel at Corporate level.
Responsible for performing trending to monitor internal and external product quality issues. Support product transfer as required.
Bachelor’s Degree in Engineering.
Three (3) to five (5) years in the manufacturing environment, preferably Medical Device or Pharmaceutical industries.
Master Degree in Engineering.
Cero (0) to two (2) years in the manufacturing environment, preferably Medical Device or Pharmaceutical industries.
EIT or PE License preferred. Active member CIAP
Skills and Knowledge :
Good oral and written communication skills (English and Spanish).
Computer Literate (Microsoft Office, Project Management, Statistics)
Able to develop technical documentation such as Validation Protocols, Technical / investigation reports, SOP, Validation Plans, Functional Requirements, Change Controls, and others.
Problem solving and analytical thinking skills
Knowledge in Lean And Six Sigma concepts.
Knowledge of statistical techniques : SPC, DOE, Process Capability and Gage R & R.
Teamwork oriented and self- starter
Frequent use and application of technical standards, principles, theories, concepts and techniques.
Provide solution to a variety of technical problems of moderate scope and complexity.
Contributes to the completion of milestones associated with specific projects. Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources.
Primarily internal company contacts. Infrequent inter-organizational and outside customer contacts on routine matters.
Supports validation process by developing or reviewing projects schedules, qualification protocols reports, audit report, validation plans, technical reports and equipment assessment, FMEAS.
Determines software validation requirements by verifying and testing activities conducted throughout the software life cycle and verifying proper operation of software in its intended use.
Complies with 21 CFR Part 11 validation requirements by preparing and / or evaluating computer life cycle documentation which includes gap analysis, impact analysis, remediation plans, design specification, vendor audit, computer validation protocols, traceability matrix, and others;
determining computer systems deficiencies.
Determines validation requirements by evaluating change control notices impact that validates equipment or systems.
Evaluates validation and / or qualification documentation by indicating deficiencies and determining the extent of re-
Supports manufacturing and facilities departments by developing, coordinating, training and implementing programs towards the qualification and certification of packaging and manufacturing process equipment, facilities and critical utilities such as compress air, breathing air and HVAC, as required.
Supports investigations and implementation of corrective and preventive actions by preparing anomalies and discrepancies reports and answering to CAPA reports in a timely manner.
Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications;
establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies.
Contributes to team effort by accomplishing related results as needed.
Supports continual improvement process by the design and / or implementation of methods and procedures for inspecting, testing, and evaluating the precision and reliability of products and / or production and / or test equipment.
Resolve product quality internal and external issues by the use of Failure Analysis systems. Analyze reports, internal product quality trends and / or return products to recommend corrective action for problem root causes.
Contributes to reduce customer complaints, Process and Supplies non conformances by handling of all Product / Process investigation System.
Complies with Internal / External audits inspections by participating in Supplier / Internal audits as required.
Complies with Internal / External audits inspections by preparing documentation for inspection / testing procedures and participating in Supplier / Internal audits as required.
Contributes to solve reliability issues and / or answer general product questions by interact with costumers either telephonically or in person.
Develop key personnel or serve as technical liaison in Quality Assurance / Validation process / GMP / FDA-QSR statistical techniques related topics and others.
Generates and monitors internal and external product quality trend metric and goals.
Pall Corporation is an Equal Opportunity Employer who encourages diversity in the workplace. All qualified applicants will receive consideration for employment without regard to gender, race, color, national origin, ancestry, citizenship, religion, age, physical or mental disability, medical condition, sexual orientation, gender identity or gender expression, military or protected veteran status or marital status.
Danaher Corporation OverviewDanaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide.
Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions.
Our globally diverse team of 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage.
We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries.
We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders.
Come join our winning team.