The Senior Engineer, Quality Assurance for Mammotome is responsible for supporting Design Control and Risk Management activities to bring new products to market, ensuring product compliance to applicable standards and regulations, and collaborating with cross-functional teams to maintain adherence to Mammotome's Quality Management System.
This position reports to the Senior Manager, Design Assurance and is part of the Quality Assurance and Regulatory Compliance department located in Cincinnati, Ohio and will be an on-site role.
In this role, you will have the opportunity to: - Serve as the Design Quality Lead during all stages of design controls projects with manageable risks and resource requirements through support of user needs, product requirements, design specifications, design verification and validation strategies, usability studies, process qualifications, design reviews and transfer.
- Generate and independently maintain project risk management file for New Product Development (NPD) and sustaining projects, including risk plans, hazard/failure mode effects analysis, risk mitigations and effectiveness checks, and risk management reports using principles from ISO 14971.
- Provide independent technical support of design control and risk management to advance problem solving of systemic quality issues and in support of internal and external audits (i.e. FDA, ISO, and MDSAP).
- Author updates to applicable corporate quality procedures in response to new standards, regulatory requirements, or process improvement initiatives-ensuring the Quality Management System (QMS) remains compliant and efficient.
- Assist in training company employees, other Design Assurance Quality Engineers on the principles of Quality and other QMS elements.
The essential requirements of the job include:- Bachelor's degree in engineering from an accredited college or university
- Minimum of 5 years of experience in an engineering role in the medical device industry
- Comprehensive knowledge and experience of international medical device quality systems regulations and standards, including but not limited to 21 CFR 820, ISO 13485, and ISO 14971
- Strong knowledge and experience in the application of design control principles to medical device design and development
- Knowledge and experience with process validation and manufacturing qualifications
Travel Requirements:- Ability to travel - Must be able to trave up to 10% of the time. Overnight travel will be required.
- Must have a valid driver's license with an acceptable driving record
- Ability to lift, move or carry equipment up to 10lbs
It would be a plus if you also possess previous experience in:- Leading audits with external auditors and/or Notified Bodies
- Non-product software validation
- Professional Certification (e.g. Certified Quality Engineer, Six Sigma
Mammotome, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
The annual salary range for this role is $100,000 to $120,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.
This job is also eligible for bonus/incentive pay.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
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