Sr. Design Quality Engineer:

• Title: Sr. Design Quality Engineer
• Location: Miami, FL
• Industry: Pharmaceutical
• Salary: $40/hr and up based on experience
• Employment Type: Contract to hire

• Ensure compliance with applicable FDA and international regulatory laws/standards specifically 21 CFR 210, 211, 820, and 4.
• Deploy and effectively execute foundations for risk management and design control in accordance with ISO 14971:2019 and/or ICH Q9.
• Draft, review, and approve specifications, procedures, master validation plans, protocols, and reports for new product development and sustaining commercial activities.
• Ensures Quality by Design (DFSS) tools are implemented appropriately; including those for risk management, reduction of variation, waste, and customer complaints.
• Collaborate closely with product development and operations on all activities to deliver high quality products to our customers.
• Execute engineering, verification, and validation studies in manufacturing and research and development environments.
• Carry out Continuous Process Verification (CPV), Annual Product Quality Review, post market surveillance, and other product and process lifecycle reports.
• Performing statistical analysis and developing models to support the sampling plans, stability extrapolations and other ad-hoc analysis that is needed by the business.
• Perform and interpret all statistical analysis techniques for design verification, process validation, sample size determinations, ANOVA, Control charts, Hypothesis testing, tolerance interval analysis, and capability analysis.
• Implementation of Corrective and Preventive Action and other quality improvement projects.
• Coordinate activities for Design Controls, Risk Management, Validations and other Quality body of knowledge and/or standards as applicable to the development and release of pharmaceutical products.

• Experience in GxP development, manufacturing and testing of pharmaceutical, biotechnology, or medical device products.
• Experience in transdermal delivery device or combination product industry is desirable.
• Experience in conducting design verification and validation studies in manufacturing and R&D setup.
• Experience in creating and maintaining Risk Management files in accordance with ICH Q9 and/or ISO 14971
• Working knowledge of quality tools such as: Design of Experiments, Root Cause analysis and/or Problem-solving approaches.
• Passion for pharmaceutical / combination product development and market supply through commercialization.
• Cross functional collaboration and team leadership skills.
• A bias for action taking and initiative to deliver on commitments.
• Ability to influence decisions with clear presentations of data and recommended solutions
• Detail oriented with strong statistical expertise. Ability to summarize complex data into clear and conclusive results. Resolve items that do not meet the requirements.
• Broad technical ability including engineering skill sets or experience or strong experience in product and equipment mechanical design, process understanding, qualification, verification and validation.
• Experience in Medical Device Software is preferred.

• Bachelor s degree in Mechanical, Biomedical, or Chemical Engineering preferred. Bachelor s degree in other Engineering or Science discipline with relevant design controls and validation experience could be considered. A Master s degree in related field is desirable.
• Statistical Analysis experience is preferred.
• Candidate should possess proven track record of successful new product introduction, managing design changes for existing products, and engineering applications.
• 6-10 years or more of professional experience in a regulated environment is required.

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to match professionals rapidly and precisely to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
EOE/ADA