- Design Controls
- FDA Regulations
- Communication Skills
- ISO 13485
Ximedica is an ISO 13485 certified and FDA registered full-service product development firm with offices in Providence, Minneapolis, San Francisco, and Hong Kong. We have an exclusive focus on medical products and over 25 years of experience developing medical devices, combination products and consumer healthcare products.
We have a high-energy collaborative culture that fosters the creative spirit while exceeding client expectations. We offer tremendous opportunity for professional development and leadership, rewarding projects, competitive salaries, an excellent benefits package, and summer hours.
Position: The Quality Engineer applies best practices from within the field of quality control to ensure that the materials, components, processes, and manufacturing techniques used produce high quality and reliable products. They review design or process changes for impact to quality, and the design history file.
Nature of Role: Reporting to the Director of Quality Services, this ‘go-to’ resource stays abreast of current quality and regulatory trends and ensures the successful integration of quality assurance and regulatory compliance, working across multiple teams and medical device/equipment categories
Bachelor's degree in a scientific or engineering field is required
Experience in a quality engineering role in the medical, electronics packaging, high reliability, or a related industry with manufacturing & assembly processes
Strong written and verbal communication skills are required, including proficiency with standard office productivity suite and data analysis software
ISO Lead Auditor training is preferred
ASQ CQE preferred
High level of competence in Quality Technology including statistical techniques, control charts, sampling plans, quality costs, design of experiments, correlation and regression, analysis of variance, probability, etc.
Experience with design review and design control
Experience with FDA GMP practices, CAPA and non-conforming materials (NCMR) processes
Ability to travel occasionally to suppliers as required by projects, which may include Asian or other off-shore partners
Our fast-paced environment demands the ability to manage multiple projects within various disciplines and deadlines. High-energy, self-starters with the following qualities:
Successful communication skills, business acumen and assertive decision-making ability
Flexibility to multi-task and perform a wide range of activities
Excellent computer skills, including MS Office proficiency
Self-motivated and capable of working with minimal supervision
Takes an active role to ensure products meet corporate, industry, and regulatory standards
Assists management in implementing and maintaining a quality system that is compliant with ISO 13485 and FDA quality system regulation requirements
Evaluates changes to design and/or manufacturing process for impact to DHF. Leads and executes activities to close any gaps, such as additional verification testing or updates to risk documentation.
Develops manufacturing control plans for internal and outsourced processes. Manages work completed by third party suppliers or contractors, ensuring deliverables meet Ximedica procedures and standard of quality.
Ensures suppliers are on the approved vendor list, evaluates supplier appropriateness, and audits suppliers if required by Ximedica processes. These may be remote or in person audits.
Completes component part qualification activities not limited to, but including first articles, cap studies, gage R&R, and implementation of SPC requirements
Develops and initiates standards and methods for inspection, testing, and evaluation, utilizing knowledge in engineering fields such as electrical, or mechanical
Develops, documents, and validates inspection and test methods to support design control, in-process inspection, and final inspection activities utilizing knowledge in engineering fields
Performs internal quality and design control audits
Performs product and process risk assessment activities, including hazard analysis and design/process failure modes & effects analysis (DFMEA/PFMEA)
Supports product/process transfers during pilot and manufacturing builds
Conducts design for manufacturability reviews and suggests improvements to aid in capability and measurement analysis
Lead or assist in quality evaluation of returned products and support RMA program as assigned
Lead, participate in, or coordinate Internal Corrective Action initiatives as assigned
Participates in the technical review of design input specifications and design documentation for new and existing medical devices as assigned
Additional support in quality services or quality systems activities as assigned.