Staff Quality Assurance Engineer (Smith & Nephew, Inc., Austin, TX) Job at Smith & Nephew
Staff Quality Assurance Engineer (Smith & Nephew, Inc., Austin, TX): Provide quality leadership to new product development project (PDP) and/or sustaining project teams as the Quality Engineering representative on projects requiring FDA 510k, CE Mark, and international regulatory approval. Determine methods, techniques and evaluation criteria for medical devices, specifically High Frequency surgical equipment. Serve as key resource for ISO, EN, MDD, MDR, and QSR requirements. Lead new product development project (PDP) and/or sustain project teams as the Quality Engineering representative on projects requiring FDA 510k, CE Mark, and international regulatory approval. Ensure compliance to product specific standards, cGMP, QSR, US FDA, ISO, IEC, UL, EN, MDD / MDR, and NMPA requirements and the scope of the Quality System. Support continuous improvement activities (CCRs and/or PARs), Post Market Surveillance activities, Management Review, audits and inspections. Support manufacturing operations and provide expertise in product requirements, risk management, test methods, and statistical analysis. Monday – Friday, 40 hours per week.
MINIMUM REQUIREMENTS:
Must have a bachelor’s degree in Electronic Engineering, Electrical Engineering, Computer Engineering, Medical Device Engineering or a related technical field plus 8 years of post-baccalaureate experience in the job offered or related role in the medical device or related industry OR a Master’s degree in Electronic Engineering, Electrical Engineering, Computer Engineering, Medical Device Engineering or a related technical field plus 6 years of experience in the job offered or related role in the medical device or related industry.
Of the required experience, must have 6 years of experience in assessing compliance with Medical Device Regulatory requirements such as, GMP’s, ISO 13485, ISO 14971, IEC 62304, IEC 60601, MDD / MDR, or NMPA and their impact on the medical device lifecycle.
Of the required experience, must have 5 years of experience in each of the following:
Of the required experience, must have 3 years of experience in each of the following:
Required travel of up to 10%.
Of the required experience, must have 6 years of experience in assessing compliance with Medical Device Regulatory requirements such as, GMP’s, ISO 13485, ISO 14971, IEC 62304, IEC 60601, MDD / MDR, or NMPA and their impact on the medical device lifecycle.
Of the required experience, must have 5 years of experience in each of the following:
- Preparing and leading software and design verifications, design validations, reliability testing, and test method development for medical device embedded system products.
- Performing requirements verification in an Agile environment.
- Developing scripts for testing firmware/software in C and/or Python programming languages.
Of the required experience, must have 3 years of experience in each of the following:
- Reviewing and updating System Risk documents to comply with ISO 14971.
- Software development lifecycle per IEC 62304.
Required travel of up to 10%.
Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.
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