Sr Quality Engineer, New Product Development - IVD (527347)

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.

Grifols Diagnostic Solutions Inc in San Diego CA is seeking a Senior Quality Engineer. The Senior Quality Engineer 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 bachelors 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.

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 bachelors 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 development and/or hardware/software development is a required.
• 5 years of prior experience working in a regulated environment is required.
• 3 years of prior experience with leading and/or performing investigations is required.
• Prior experience working with an electronic document management system is required.
• Experience implementing design controls is a plus.
• Prior experience working with SAP is a plus.

Equivalency

Depending on the area of assignment directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a bachelors degree plus 4 years of experience an equivalency could include a masters degree with 2 years of experience.

Occupational Demands

Work is performed in an office environment with exposure to electrical office equipment. May occasionally enter BioRisk Area. Exposure to biological fluids with potential exposure to infectious organisms. Personal protective equipment required such as protective eyewear garments and gloves. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast simple movements of the fingers hands and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Drives: varies may or may be required to frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.

Pay Scale

The estimated pay scale for the Sr Quality Engineer based in San Diego CA is $131252.95 to $164065.90 per year. Additionally the position is eligible to participate in up to 15% of the company bonus pool. We offer a wide variety of benefits including but not limited to: Medical Dental Vision PTO PPL up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education experience skillset knowledge where the role is performed internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909 Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years and you can grow with us!

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties responsibilities or requirements. Managers and supervisors may assign other duties as needed.

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Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active nonexpired Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws.

Location:NORTH AMERICA : USA : CA-San Diego:USSDW - San Diego CA - Willow Ct Mfg

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