Quality Inspector III - Plymouth, United States - Silk Road Medical

Description

Silk Road Medical, Inc. is a medical device company located in Sunnyvale, California & Plymouth, MN, that is focused on reducing the risk of stroke and has pioneered a new approach for the treatment of carotid artery disease called TransCarotid Artery Revascularization (TCAR).

We are always looking for dynamic and innovative individuals who are passionate about reducing the risk of stroke. We welcome team members who approach their work with courage, flexibility, persistence, and a willingness to assist others with a strong emphasis on collaboration.

The opportunity

The Quality Control Inspector III will work with Quality and Operations to facilitate the inspection and testing of components, assemblies, and products to ensure they meet established specifications and requirements. At a professional level, follows procedures and processes to complete tasks. Makes simple updates to procedures. Assists in the training of new QC Inspectors and serves as resource to less experienced inspectors.

This is an on-site position located in Plymouth, MN.

A "Day in the life"

• Performs complex inspections and review of components, assemblies and devices per applicable drawings, LHRs and specifications; maintains accurate and up to date records of all materials. These activities may be conducted on incoming, in-process and returned materials.
• Carefully reviews and checks the accuracy of their work and increased volume of checking others' work.
• Works on assignments that are moderately difficult in nature where judgement is often required.
• Provides input and support for product testing of significant scope throughout the lifetime of the product (prototypes, DV&V, post-production, etc.) with minimal guidance.
• Initiates and is a key contributor in executing nonconforming product actions.
• Supports the ISO, EN, and MDR certification processes and compliance to FDA regulations by ensuring compliance to all applicable policies, procedures and guidance documents while performing assigned tasks and duties.
• Contributes to a safe work environment by meeting company safety policies and all regulatory requirements.
• Trains others on complex QC activities.
• Identifies opportunities for improvement and provides/suggests plan for improvement; implements if within QC preview. Submits change orders.

What you'll bring

• High school diploma or education/experience.
• 2+ years of quality inspection experience.
• Medical device or regulated industry experience.
• Demonstrated ability to use hand measuring tools (caliper, snap gauge, micrometer, ping gauge, etc.).

Additional skills you have

• Understand drawings and specifications but requires some guidance during application.
• Has a solid grasp on all aspects of the QC inspection process.
• Knowledge of GDP, SOP, ISO 13485 and 21 CFR 820, GMP.
• Knowledge of AQL sampling method.
• Sedentary work that primarily involves sitting/standing and keyboarding.
• Occasionally, lifting, carrying, pushing, pulling objects up to 40 pounds.
• Occasionally, repeating motions that may include the wrists, hands and/or fingers.
• Occasionally, operating machinery and/or power tools.
• Occasionally, stooping, reaching overhead, reaching at or below shoulder level.
• Occasionally, working in noisy environments.

What we offer

Our philosophy is to make all benefits affordable to all Silk Road Medical employees and their dependents. We offer robust and affordable benefits with modest employee contributions. Click here for more information

Our Commitment to Diversity, Equity & Inclusion

We welcome all people who want to be part of our amazing journey and mission to provide new, innovative, and clinically proven transcarotid therapies to prevent the devastating burden of stroke. Our employees come from very different backgrounds: different races and ethnic backgrounds, different religions, and different parts of the world. Some of us are married to people of the opposite sex and some to the same sex, some are not married. Some of us are becoming parents for the first time and others are counting down the days to retirement. Some of us do cartwheels every day and some need physical accommodation to best perform their role. All are welcome.

We have a diverse workforce because we believe that it is possible for people with different backgrounds, viewpoints and persuasions to come together and debate important topics, learn from one another, and make better decisions than we would if we all were all the same. We want Silk Road Medical to not only be a great place to work, but The Greatest Place to Work and we strongly believe that a diverse and inclusive working environment is critically important to that goal.

Silk Road Medical is an equal opportunity employer and we value diversity at our company. We strictly prohibit unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity, national origin/ancestry, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.