Sr. Manufacturing Quality Engineer
Full Time
San Carlos, CA
$102,400 - $153,600 a year
Posted
Job description
The Company
Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple disease states. Based in Silicon Valley and backed by well-known institutional investors, our incredibly talented team of 150+ engineers, innovators and industry leaders brings years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics & Hansen.
The Manufacturing Quality Engineer reports to the Manufacturing Quality Engineering Lead or equivalent manager. This position provides hands-on guidance and leadership from a Quality and Regulatory perspective to the team throughout the product development cycle, especially with V&V and Design Transfer stages. The focus is to provide engineering support so high quality products can be produced in a world class manufacturing infrastructure. We are looking for someone that is highly motivated in their career growth, a self-starter, a team builder, and an excellent communicator.
Responsibilities:
- Provide hands-on leadership and guidance to Design Transfer requirements, Risk Management, Manufacturing processes, incoming and in-process inspection and test methods/specifications, Process Validation (including sterilization), and finished product release activities.
- Participate in product development teams and represent Quality function as needed. Provide relevant input to the product development planning process according to project milestones and QMS implementation /requirements/trace matrix.
- Define, implement, and provide training on relevant aspects of Noah Medical’s Quality Management System to meet US FDA and International requirements.
- Work with key suppliers on qualification, process capability, quality issues and process improvement.
- Provide hands-on leadership and guidance to Design Transfer requirements, Manufacturing processes, incoming and in-process inspection and test methods/specifications, Process Validation (including sterilization), and finished product release activities. Grow in QE/QMS expertise as defined by the manager.
- Participate in QE/QMS activities not specified here and as assigned.
Requirements:
- BS in Engineering or Technology, Mechanical, Industrial, Electrical, Manufacturing, Life Sciences, or equivalent.
- Minimum of 4 years of work experience in the medical device field and a minimum of 2 years experience in a QE/Mfg function or equivalent.
- Experience in production environments that meet world class regulatory requirements such as ISO/FDA Quality Management System requirements.
- Experience in inspection/test method development and validation for IQC, In-Process, and Final release requirements.
- Experienced with Process Validation .
- Experience in supplier selection, qualification and improvement.
- Experience with Risk Analysis, FMEAs, Hazard Analysis, GD & T requirements.
- Experienced with statistical skills to define/train on test sample size and data analysis techniques.
- Experienced in Microsoft Office and other software tools such as Google Suite, Jama, and ePLM/eQMS systems, or equivalent.
- Must have attention to details, be a self-starter, a team builder, and excellent in verbal and written communication.
- Preferred but not required: experience with Software Validation, with both disposable/sterile devices and capital/electronic equipment. Certifications: ASQ CQE certifications, 6 Sigma, ISO Auditing, etc.
midpoint is $128,000
Consistent with applicable laws, an employee's pay within this range is based on a number of factors which include but are not limited to relevant education, skills, job-related knowledge, qualifications, work experience, credentials, and/or geographic location. Noah Medical reserves the right to modify this range as needed. Please note that the aforementioned range is only one component of the position's total compensation package. In addition, this position may be eligible for bonuses, stock and employee benefits including but not limited to PTO, paid holidays, health insurance, dental & vision insurance, life & disability insurance and a 401k plan. Additional details on the compensation package and employee benefits offerings will be provided to candidates during the interview process.
Noah Medical is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to ensuring an inclusive environment for our employees. Applicants are considered for all positions without regard to race, color, religion, sex or gender, gender identity or expression, sexual orientation, national origin, ancestry, age, genetic information, physical or mental disability, marital or protected military or veteran status, or any other consideration made unlawful by federal, state or local laws.
To all recruitment agencies: Noah Medical does not accept unsolicited 3rd party agency resumes. Please do not forward resumes to any Noah Medical employees. Noah Medical is not responsible for any fees related to unsolicited resumes and we will not pay fees to any third-party agency or company that does not have a signed agreement with Noah Medical.
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