Invuity, Inc. offers a fast-paced, entrepreneurial environment with competitive compensation packages including salary, benefits and equity participation. Invuity is an equal opportunity employer. Principals only need apply. No recruiter calls please.
Job Listings:
- Provide leadership and support to new product development project teams.
Generate/approve validation studies, capability studies, FMEA/Hazard analysis. - Responsible for compliance to design control activities, environmental monitoring, sterilization validation, and shelf life requirements.
- Collaborate with engineering, manufacturing, and regulatory, and work with outside labs and suppliers.
- Support manufacturing operations and provide expertise in statistical process control, min/max studies, and evaluation of control charts.
- Contribute to the reporting, analysis, and resolution of material non-conformance incidences related to manufacturing processes.
- Contribute to the timely resolution of product complaints and/or safety issues.
- Ensure that compliance to cGMP and EN/ISO 13485/MDD requirements are maintained.
- Ensure that all the responsibilities within the scope of this job comply with the scope of the Company Quality System.
- Requires a Bachelor’s degree in engineering or life sciences and a minimum 5 years experience in the medical device industry.
- Must be able to make decisions related to product quality and release of company products.
Requires ability to assess current company practice with external standards, guidance, and regulations. - Must be able to provide and implement solutions to quality problems.
- Requires the ability to understand the impact of GMP’s, ISO 13485, and MDD requirements on company’s new products.
- Excellent verbal and written communication skills
- Flexibility to handle multiple tasks and meet time lines.
- Ability to work in a matrix/team environment.
- Six Sigma Experience a plus.
Quality Engineer
Summary: This position will implement, support, and sustain elements of the company’s quality system through procedure generation, training, auditing, and technical support. The quality engineer serves as a key resource for ISO, EN, MDD, and QSR requirements.
Essential Duties and Responsibilities:
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required.
Please send resumes to careers@invuity.com for future consideration.