Senior Quality Engineer, New Product Development - IVD

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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Sr Quality Engineer, New Product Development - In vitro diagnostics (IVD)

 

Summary

The Sr Quality Engineer is located at our Grifols Diagnostic campus in San Diego California and will function as a quality lead on cross-functional teams focusing on New Product Development (NPD) and Life Cycle Management Projects. The role will provide technical support and ensure that correct and appropriate specifications have been transferred to QC and Production and that product specifications and final performance characteristics are aligned with product claims. To be able to fulfill this role a minimum of a bachelor’s degree and 10 years of prior experience with new product development, assay development and/or hardware/software development is a required. We are looking for an individual with IVDR and FDA knowledge, strong technical writing skills, excellent presentation and communication skills who has worked in a regulated field under ISO 13485 and experience in performing risk assessments per ISO 14971.

 

Why Grifols:

Our sustainable growth strategy provides stability and room for your professional growth while driving innovation with us. This role will contribute to the development of new product for transfusion medicine safety and the early disease detection.

 

Primary responsibilities

• Provide QA/Engineering support as the quality representative on cross functional teams for new product development of reagents, assays and software, including software development lifecycle, SDLC.
• Independently write, review, and approve technical documentation including plans, analytical and clinical protocols and reports.
• Design control: Provide guidance to project managers on design documentation requirements and review/approve the design documentation for new products in development.
• Independently conducts and reviews data analysis to make informed decisions regarding study results.
• Conduct product safety risk assessments, provide feedback, and document per ISO 14971.
• Ensures governing documents for new product development are in accordance with regulations (such as ISO 13485, ISO 14971, IEC 62304, and 21 CFR 820) and company policies.
• Collaborates, sets up meetings, determines action plans, performs troubleshooting and finds a solution which are clearly communicated with members of a cross-functional team.
• Assists in Audit and Inspection preparation as lead subject matter expert for new product development and product quality.

 

More about us, benefits we provide you

• salary and annual bonus, see details below
• flexible working hours, 80% on site and 20% remote
• PTO, paid Holidays, Paid Parental Leave
• Professional development opportunities (training, career development)
• Gym pass, Employees perks program
• 401 (K) Retirement Plan match
• Health insurance: Medical, Dental, Vision
• Travel accident insurance, Life and AD and D Insurance
• Short- & Long-Term Disability Insurance
• Health Savings Account, Flexible Spending Account
• Critical Illness, Accident, Hospital Indemnity coverages
• Adoption Assistance
• Employee assistance plan

 

About you:

Knowledge, Skills, and Abilities

• Knowledge of formulation design and manufacturing process.
• Strong communication skills with an ability to convey ideas clearly to all levels within a cross functional team.
• Proficient in Microsoft Office Suite.
• Knowledge of Good Manufacturing Practice (GMP) procedures.
• Willing to work collaboratively to identify and implement a sustainable solution.
• Strong attention to detail and ability to analyze data using statistical software.
• Strong project management and organizational skills with the ability to work on multiple projects with competing deadlines.
• Can independently prepare presentations and write procedures, reports, forms, etc.

 

Education & Experience

• Minimum bachelor’s degree in molecular biology, biology, chemistry, biomedical engineering, or a related field
• Quality certification (from American Society for Quality or equivalent) is a plus.
• 10 years of prior experience with new product development, assay develo