myoscience is a growing medical device company located in Silicon Valley. Our team is revolutionizing treatment for Beauty and Health with our patented Focused Cold Therapy ™.
We describe ourselves as dedicated individuals, who value each other’s contributions and are committed to greatness. The people in our team know how to stretch their imaginations to deliver innovation; they take a unique approach to the way they do business: out of the box thinkers.
“Well done is better than well said.”
The Quality Engineer is responsible for both internal Quality Systems maintenance and Quality Engineering oversight at the contract manufacturer. This includes playing a key role in the manufacturing transfer of new products from product development to contract manufacturers. In addition to release of new products, you will also manage the quality engineering activities for existing products at the contract manufacturer and will be the main point of contact for internal maintenance of quality system activities.
As the ideal candidate you:
- Be the main point of contact for day-to-day oversight of the CM from a
o quality engineering,
o process compliance and
o quality system compliance
- Ensure accurate and compliant deployment of changes (DCOs)
o Make sure all aspects of a DCO is appropriately executed at the CM
o Product disposition, Training and Certification, Document Control on the line etc.
o Perform “First Article” inspection of product to ensure implemented changes are in effect and the process is repeatable
- Assist myoscience ME with training and certification activities
- Be the technical “canary in the coal mine” for myoscience to provide us leading indicators of issues in production
- Assist CM in performing accurate trending of production metrics
- Perform unannounced audit of production line, CER
- Generate, manage and drive to closure SCARs opened for CMs
Note: The above listed responsibilities of the role will be part-time (ex: 3 days or 4hrs/day @ CM site)
The other key responsibilities include:
- Manage critical Quality System related functions internally at myoscience as we scale:
o Complaint management and trending
o CAPA management
o CATF management
o SCAR management
o NCMR management
o Internal Audit logistics and execution
- Be the backup to Document Control
- BS in Electrical Engineering, Mechanical Engineering or related engineering fields
- 5 years of experience with medical device quality engineering activities, both internally and outsourced in biomedical or life sciences
- Demonstrated experience in technical project/program leadership and management, including processes and staff
- Demonstrated ability to communicate and work collaboratively across functions, including other engineering and product groups
- Experience across all product lifecycle phases
- Lean and/or Six Sigma experience a plus
“We are what we repeatedly do. Excellence, therefore, is not an act but a habit.”
- This is a “big” job with a lot of responsibility
- You must be a boy scout – always prepared to get stuff done!
- A penny saved is a penny earned – you must focus on doing more with less and driving down COGS
- We have a wicked sense of humor
- We're innovative and flexible
- We are risk-takers and not afraid to make mistakes, because that is how we learn!
Our office is located in a state of the art campus with a free gym, spa facility, athletic fields, organic café and a beautiful park on the shores of Redwood City.
We offer a comprehensive benefit packet designed to support your ability to meet goals and maintain work/life balance. Our compensation philosophy is designed to reward the achievement of challenging objectives. Challenging objectives? Yes, but we promise the results and the journey are going to be worth it!