Senior Quality Design Engineer
Senior Quality Design Engineer
Our Client in Milford, MA is looking for a Senior Quality Design Engineer, this is a 3-6 month contract position.
This position will be responsible for concurrent quality engineering activities associated with new product development, on-market design change, risk management, quality systems and Waters requirements for instrument hardware and software.
Primary responsibility will be to provide quality engineering support in the following areas: design controls, risk management, change control, previous product analysis, post market review, quality planning, continuous improvement, establishment of appropriate requirements management and traceability.
- Participate in new product development projects by providing technical quality engineering support for assigned projects. Ensure engineering and scientific analyses are employed and design history files comply with company policies and applicable standards and regulations. Transfer knowledge of inherent product design risks and mitigating controls resulting from the design process to colleagues.
- Key deliverables include but are not limited to performing previous product analysis on similar products and risk management activities. Supporting project team activities for requirements management, design reviews, design verification, design validation, design transfer to manufacturing, documentation completion tracking, and product release authorization for distribution of product.
- Facilitate Risk Management activities according to company policy, procedures and ISO 14971, including Risk Management Planning, Preliminary Hazard Analysis, FMEA, Software Risk Analysis, Risk Management Report and Risk Management File.
- Work with global Design Quality Assurance peers and Product Development stakeholders to identify and develop improved or harmonized Product Development processes/systems and drive implementation within the relevant development areas.
- Monitor Projects, PIM Investigation Tracker, ECR’s, Deviations, Defect Tracking Systems and First System Install Reviews to identify product quality trends and translate this information into improved product designs. Facilitate and participate in Root Cause Analysis of identified product and process deficiencies initiating system corrective actions as required.
- Act as Quality signatory on Product Development deliverables ensuring that company and departmental objectives are met.
- Work cross functionally and within Waters Global Quality Assurance to ensure activities and potential improvement work is aligned and harmonized.
Education and Experience Requirements:
- Minimum of a Bachelors degree in Engineering or Science related function, or 3+ years of proven relevant experience in a regulated Engineering/Science related function, or 1+ years of similar proven experience with a Masters.
- Experience in the application of production and process controls including process validation, process control plans and statistical process control.
- Experience in product development of complex systems (mechanical, electrical, and software).
- Working knowledge and experience with ISO 9001.
- Working knowledge and experience with ISO 13485, 21 CFR Part 820, IVDD 98/79/EC, MDD 93/42/EEC, IVDR 2017/746/EU and MDR 2017/745/E.
- Working knowledge and experience with 21CFR820 Design Control, ISO62304, IEC62366-1 or equivalent is desired.
- Experience with Root Cause Analysis techniques e.g. 8D, 5 Whys, Cause and Effect Analysis and knowledge of continuous improvement techniques.
- Experience in Design for Six Sigma, Manufacturability, Service, Inspection is desired.
- Working knowledge of (LC/MS) instrument performance, use, customer experience, construction, and functionality and broad experience in LC/MS product evaluation and testing is desired.
Other skills and experiences:
- Good technical writing and oral communication skills are required to ensure succinct report generation, and effective communication with staff, peer groups and across organization.
- Ability to constructively challenge designs and engage in transparent conversations.
- Strong analytical skills with the ability to identify, analyze, and solve problems with minimal direction and make decisions with confidence.
- Strong project management skills, proven ability to facilitate activities, balance and prioritize multiple ongoing projects/tasks, lead teams, contribute effectively in a team environment and build strong working relationships.
- Demonstrated ability to apply system quality management practices in efficient and effective ways while ensuring compliance. Solutions-based approach to quality to provide “added value” to company.
- Be accountable for quality of their work, by adopting a “right first time” approach.
- Must be able to work independently and communicate with all levels of the organization.
- Foster an environment that values diversity and inclusion.
- Computer literate, preferably with knowledge of software packages such as Word, Excel, and PowerPoint to for example; reports, presentations, analyze data, etc.