Sr. Design Quality Engineer
Miami, FL US
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
Responsible for quality engineering activities throughout the product lifecycle including design, development, risk management, design verification and validation, design transfer, process validation, and manufacturing of transdermal drug delivery systems / combination devices. Participate in activities related to Design controls, Risk Management and Quality System requirements supporting product development projects and commercial manufacturing activities. Coordinate and lead activities relating to Analytical Research, Product and Process Development, Qualifications, Validations, Annual product quality reports and Continuous Process Verification. Provide expertise for statistical techniques for sampling and data evaluation. Foster a culture of compliance and identify and implement continuous improvement projects.
- 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.