Sizewise manufactures and delivers durable medical equipment throughout the continental U.S. We are proud to say our products are manufactured in one of four U.S. based plants. We are actively seeking a Quality Control & Compliance Engineer.
Overview of tasks:
- Reviews, modifies, and prepares the following for compliance activities: Risk Management Files, Pre-Production FMEA, Design Control Plans, Design History File documentation, Test Report Forms, Instructions for Use, Labeling, and Certification Checklists. Works collaboratively with Engineering and Quality to create and manage Device Master Records and Design History files so that they adequately demonstrate product compliance. Manages all required reporting to agencies assuring they are timely and accurate. Ensures accuracy of certification records and Design History documentation throughout a products lifecycle.
- Works collaboratively with internal teams to develop, coordinate and document the execution of testing as required for compliance. Provides technical support for any regulatory issues. Works closely with Manufacturing and Quality to provide continuous design improvements to post release products. Conducts lower level product testing in house and contributes to the development of a more robust in house test lab capability. Assists with both new product supplier qualification and ISO 13485 plant audits.
- Reviews user documentation to ensure that required warnings, labels and symbols meet all applicable standards, codes and technical regulations. Establishes and maintains effective working relationships with various certifying agencies and testing laboratories. Responsible for Product Launch sign-off and official handoff to manufacturing. Identifies and reviews new or modified standards determine applicability and impact to our products. Participates in ISO, RESNA, and S3I standards development committees. Ensures that changes in international and domestic standards, codes and technical regulations are broadly communicated and that internal processes comply with those changes. Supports the continuous improvement of certification and compliance tools and processes.
- Bachelor's Degree (BS) in a technical, scientific or engineering discipline required
- Demonstrated past successful experience with the application of IEC 60601 and ISO standards for medical devices and/or industrial applications.
- Knowledgeable of EMC Regulations and certifications procedures applicable to Medical Devices sold worldwide including but not limited to testing documentation, certification requirements and procedures (ie: EN14971, EN60601, CISPR 11, FCC, EU, etc)
- Knowledgeable of FDA guidelines on design controls and software validation.
- Knowledgeable of risk management process (ISO 14971) and quality management process (ISO 13485) for medical devices; specifically Risk Analysis, Failure Modes Effect Analysis, and creating/conducting Verification/Validation protocols.
- Experience working directly with external Certification Bodies such as Intertek, UL
- Experience applying and monitoring RoHS, REACH, and WEEE for products.
- Skilled at using database, spreadsheet, and word-processing software to prepare statistical and written reports with varying degrees of complexity and detail for management.
- Knowledge and experience in basic 2D/3D CAD area as well as basic print reading competency.
- Manages complexities and competing priorities. Coordinates information and activities among groups with differing agendas, across multi-functional areas.
- Track record of maintaining high quality standards for the organization and implementing quality initiatives
- Ability to travel up to 50%; both domestically and internationally
- Available to work flexible schedule; some evenings, some nights, and some weekends as necessary
Sizewise provides a full benefits package which includes:
- Health & Dental Insurance through Blue Cross & Blue Shield
- Affordable premiums with health insurance deductibles of $750 individual/$1500 family
- Company paid life insurance of $50,000
- Company paid short term disability
- 401k company match with immediate vesting
- 6 paid holidays
- Paid Time Off
- Paid bi-weekly
EOE, including disability/veterans
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