Risk Management & Design Control

SummaryOur client, a research-based biopharmaceutical company delivering life-saving therapies to patients in need, has engaged GForce to identify a Quality Engineer to implement Design Controls and Risk Management activities for combination devices to integrate in with the existing Quality Management System. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Their worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Their scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining our client, you will further their mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.Duties / Expectations of RoleAct as a project engineer/manager for medical device QMS quality improvement activities, with a focus on design controls and risk management.Provide oversight of quality improvement activities and ensure compliance with FDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and other applicable domestic/international regulatory requirements, including quality system requirements.Plan and support implementation of approved quality improvement action items and deliverables.Interface with internal stakeholders and contract manufacturers to address and resolve complex technical drug-device combination product, process, and quality issues.Act as an escalation contact for complex and high impact quality issues, concerns and decisions.Support strategic relationships with internal cross-functional teams and related CMOs.Provide training as needed for cross-functional stakeholders.Provide guidance and impact assessments for Change Control, including DHF/RMF assessments.Write and/or implement changes to controlled documents (e.g., SOPs, specifications, test methods, etc.).Leads/coordinates investigations, and the development and implementation of corrective and preventative action (CAPA)Anticipates shifts in industry trends and regulatory environment that will impact business needs and positions the function to respond accordingly.Collaborate with R&D during new combination product development and provide input into the design controls process.

Mandatory RequirementsDemonstrates understanding and application of QSR/GMP principles, concepts, best practices and standards in the US and internationally.Can develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories.Demonstrates strong knowledge of medical devices, combination products and general pharmaceutical manufacturing.Can provide guidance to solving problems, uses Quality standards, regulations and industry best practices.Demonstrates knowledge of industry best practices and trends.Demonstrates excellent verbal, written, and interpersonal communication skills.5+ years of relevant experience in a GMP environment related field and a BS or BA. OR 4+ years of relevant experience and a MS.Knowledge and experience in quality assurance for development of drug-device combination productsPrevious experience with combination products is required, such as autoinjectors, co-packed kits, pre-filled syringes.QA experience in both clinical and commercial combination products.Strong project management and process improvement skills.Demonstrates understanding of domestic and internal quality systems regulations to adopt best in class systems/processes and drive continuous improvement initiatives.Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistics preferred.Knowledge of Risk Management principles according to ISO 14971, including the use of risk management tools such as FMEA.

Term & Start12–18-month contract with strong possibility of converting to FTEHybrid schedule: Onsite weekly in Foster City, CA (onsite 3 days/week)