Job summary
Job post source
This job is from a recruiting firm hiring for a separate company.
Job overview
The Senior Quality Engineer role focuses on ensuring the quality, safety, and reliability of surgical products within the medical device industry, impacting product development and regulatory compliance.
Responsibilities and impact
The candidate will provide quality engineering expertise in supplier management, design control, manufacturing, software quality, and sterilization activities, support engineering efforts, collaborate with product development teams, and contribute to usability engineering, software documentation, biocompatibility, and EMC testing.
Experience and skills
The position requires a BS or MS in engineering (mechanical, computer, or biomedical preferred), 3-5 years of quality engineering experience in the medical device industry, knowledge of consumables and sterilization processes, and understanding of Medical Device QMS and regulatory standards like FDA CFR 21 820 and ISO 13485.
Job location and travel
The position is full-time, permanent, and based in Fremont, requiring 3-5 days a week in the office.
Application process
Interested candidates should apply now or contact Jason Pho from Talent at jason.pho@talentinternational.com.
Company overview
Talent Inc. is a leading career services company specializing in professional resume writing, LinkedIn profile optimization, and career coaching. They generate revenue by offering personalized career services to job seekers, including resume writing packages, LinkedIn profile makeovers, and interview preparation sessions. Founded in 2014, Talent Inc. has grown rapidly, acquiring several smaller career service companies to expand its market reach and enhance its service offerings. The company is known for its team of experienced career experts and commitment to helping individuals achieve their professional goals.
How to land this job
Tailor your resume to highlight your expertise in supplier management, design control, manufacturing, software quality, and sterilization processes, as these are core responsibilities for the Senior Quality Engineer role at Talent.
Emphasize your experience with medical device quality systems, regulatory standards like FDA CFR 21 820, ISO 13485, and knowledge of consumables and sterilization, which are critical requirements in the job description.
Apply through multiple platforms including Talent's corporate website, LinkedIn, and other job boards to maximize your application visibility and chances of being noticed.
Connect with professionals in Talent's medical device or quality engineering division on LinkedIn to inquire about the position; use ice breakers like commenting on recent regulatory challenges in medical device quality or asking about their team's approach to sterilization compliance.
Optimize your resume for ATS by incorporating keywords such as 'supplier management,' 'design control,' 'software quality,' 'sterilization processes,' 'FDA CFR 21 820,' and 'ISO 13485' to ensure it passes initial automated screenings.
Leverage Jennie Johnson's Power Apply feature to automate tailored applications, identify relevant job portals, and discover LinkedIn contacts in Talent, allowing you to focus your time on preparing for interviews and networking.
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