Job summary
Job post source
This job is from a recruiting firm hiring for a separate company as indicated by the mention of Specialist Staffing Group and the URL realstaffing.com, which suggests a staffing agency rather than the direct employer.
Job overview
The Senior Quality Engineer role focuses on ensuring the safety, reliability, and quality of advanced surgical robotic systems, impacting product development and patient outcomes significantly.
Responsibilities and impact
The job involves leading quality engineering practices across design, manufacturing, software, and supplier quality, managing supplier quality, design control, software validation, sterilization, and collaborating on quality goals and risk mitigation, as well as mentoring junior engineers.
Experience and skills
Candidates need a bachelor's degree with 5+ years in medical device quality engineering, knowledge of FDA 21 CFR 820, ISO 13485, GMP, and experience in design for reliability and manufacturability; certifications like Certified Quality Engineer or ISO 13485 Lead Auditor and experience with sterile instrumentation are preferred.
Compensation and benefits
Direct-hire employees may be eligible for client-offered benefits including medical, dental, vision coverage, and paid leave, with eligibility depending on location and hire date.
Career development
The role offers opportunities to lead initiatives, mentor teams, and drive continuous improvement, fostering professional growth in quality engineering within a high-impact medical device environment.
Work environment and culture
The company promotes a culture of quality excellence and innovation in a dynamic, cross-functional team environment focused on life-changing medical technology.
Company information
The company is a cutting-edge medical device firm specializing in surgical robotics, emphasizing innovation and patient outcome improvement.
Team overview
The candidate will join a dynamic team working collaboratively across functions to achieve quality and regulatory compliance goals.
Application process
Candidates are encouraged to apply immediately for consideration, with no specific application steps detailed beyond submission.
Unique job features
The position is distinguished by its focus on next-generation surgical robotics, involvement in complex quality engineering areas, and adherence to global standards like ISO and FDA regulations.
Company overview
Real is a technology company specializing in mental health and wellness, offering a platform that provides accessible, affordable, and personalized mental health care. They generate revenue through subscription-based services, where users pay for access to therapy sessions, mental health programs, and self-care tools. Founded in 2019 by Ariela Safira, Real has gained attention for its innovative approach to mental health, combining digital tools with professional support to democratize mental health care. The company emphasizes inclusivity and aims to reduce the stigma associated with seeking mental health support.
How to land this job
Position your resume to highlight your expertise in medical device quality engineering, emphasizing experience with design control, software validation, supplier quality, and sterilization processes as these are central to the Senior Quality Engineer role at Real.
Emphasize your knowledge of FDA 21 CFR 820, ISO 13485, GMP, and your experience with audits and inspections to align with Real’s regulatory and quality standards requirements.
Apply through multiple channels including Real's corporate website, LinkedIn job postings, and relevant medical device industry job boards to maximize your application visibility.
Connect on LinkedIn with current Quality Engineers or team leads at Real, using ice breakers like commenting on recent innovations in surgical robotics or asking about their experience with quality challenges in medical device manufacturing.
Optimize your resume for ATS by incorporating keywords such as 'design control,' 'software validation,' 'supplier management,' 'ISO 13485,' and 'FDA 21 CFR 820' to ensure your resume passes automated screenings.
Use Jennie Johnson's Power Apply feature to automate tailored applications, identify multiple application portals, and discover relevant LinkedIn connections, allowing you to focus your energy on preparing for interviews and networking.
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