Job Function:
Quality
Job Sub Function:
Quality Assurance
Job Category:
Professional
All Job Posting Locations:
Jacksonville, Florida, United States of America
Job Description:
We are recruiting for the best talent for Staff Validation Quality Engineer, New Product Introduction to join our Contact Lens Quality organization located in Jacksonville, FL.
The Staff Validation Quality Engineer provides quality and technical leadership to ensure production processes are validated to consistently produce products meeting predetermined quality standards throughout the product lifecycle. The Staff Validation Quality Engineer will lead new product introduction (NPI) validation projects and other projects of various product and subsystem types (instruments/vision, new lines, product improvements, facility upgrades, etc.). The Staff Validation Quality Engineer will lead more complex validation activities within product, process, equipment, software and facilities changes. This role will ensure all validation activities are consistent with regulations and validation policies and procedures, establishing validation strategies and requirements that are executed and successfully implemented.
The Staff Validation Quality Engineer:
- Partners with new product introduction (NPI) project teams to establish a systematic approach to ensuring that a manufacturing process consistently delivers the new product with the intended quality, safety and efficacy.
- Collaborates with functional business partners to proactively address quality issues during new product development and product verification/validation. Ensures process capability with respect to product specifications.
- Develops Validation Implementation Plans (VIPs) that mitigate risks, maintains product integrity and ensures compliance to internal and external standards and regulations.
- Collects and evaluates data from the process characterization/design transfer stage through commercial production, establishing scientific evidence that the process is capable of consistently producing quality products.
- Ensures compliance with current quality system procedures including process validation, computer software validation (CSV), risk management, design controls and CTQ flowdown.
- Adheres to safety and environmental policies and procedures and supports departmental safety and environmental objectives.
Key Responsibilities:
- Leads complex validation activities within product, process, equipment, software and facilities changes and ensures all activities are consistent with regulations and validation policies and procedures. Leads projects of various product and subsystem types (New product introduction (NPI) and NPI line propagation, lab instruments, vision systems, new lines, product improvements, facility upgrades, etc.).
- Utilizes quality tools to track and trend quality performance and identify key opportunities for improvement through root cause analysis. Applies trend results to help prioritize the resolution of equipment, systems or processes to prevent recurrence.
- Works with cross functional teams including product development to develop measurable goals for quality. Participates in the risk management process to ensure performance aspects are mitigated in product quality plans. Provides support including failure analysis and root cause evaluations.
- Represents quality assurance in validation for multi-departmental meetings, change control, and project teams as needed.
- Compiles data and provides reports to management on a periodic basis.
- Ensures compliance through design and development to quality system procedures and quality policies including SOPs, work instructions, forms, templates, etc. Conducts training on quality concepts, tools and systems as necessary.
- Champions compliance to applicable Global Regulations and standards (e.g. QMSR, ISO 13485, EUMDR etc.) including providing support during internal and external audits.
- Performs other related duties as assigned by management.
Qualifications
- A minimum of a Bachelor’s Degree is required. Degrees in Engineering/Science/Statistics or other related technical discipline preferred, OR equivalent related experience (Certifications preferred: CQA, CQE, or CSQE, etc.)
- 10-12 years working experience in Medical Device and/or Pharmaceutical Manufacturing, Quality Engineering/Assurance or Regulatory fields.
- 6 years in medical device manufacturing and/or new product development.
- Thorough understanding of QMSR/ISO medical device regulations, especially design controls, risk management, sterilization and validation principles.
- Excellent understanding and application of principles, concepts and practices of statistical methods and root cause analysis. Data driven and able to recognize and resolve technical issues.
- Ability to interpret complex data and troubleshoot technical issues systematically
- Excellent communication and team collaboration skills
- Attention to detail and strong problem-solving capabilities.
- Familiarity with Lean Principles, Six Sigma, Process Excellence and Project Management
- Capable of demonstrating strong proficiency in Kneat and Microsoft Office Suite, including Word, Excel, and PowerPoint.
Preferred:
- Six Sigma, Lean or CQE Certification are assets.
- Strong leadership and influencing skills
- Strong communication skills
If you are under 18 years of age, you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check.
#LI-Hybrid
Required Skills:
Preferred Skills:
Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Human-Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)
