Job Description

Stryker is one of the worlds leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Product Environmental Compliance Quality Engineer (PEC QE) to join our Neurovascular division in our Fremont, CA site.

Who we want

Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes finding ways to simplify, standardize and automate.

Data managers. People who enjoy compiling, organizing and consolidating large volumes of data and reports.

Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

What you will do

As the PEC QE; you will evaluate regulations and make recommendations as necessary for maintaining compliance with product environmental regulations specific to medical device and packaging materials. You will support new product development, new business development (acquisitions), and changes to existing product and ensure compliance by completing thorough assessments and completing the appropriate documentation pertaining to product material environmental compliance.

* Operate with some latitude for independent action or decision, and reviews progress with management.
* Provide input into the work of other cross-functional resources within regulatory affairs, product engineering, technical publications and operations.
* Advocate of product environmental compliance to state of the art practices.
* Responsible for the product environmental compliance process, database and supplier relationships.
* Assist in the management of the Product Environmental Compliance process, including process maps and procedures.
* Report observations/ problems clearly and concisely and takes appropriate actions.
* Develop and apply a broad knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.
* Responsible for execution of environmental compliance tasks, with emphasis on technical activities.
* Develop knowledge and skills in areas of regulatory pathways, and risk-benefit analysis
* Provide support for product submissions, registrations, obtaining approval/clearances, technical documentation, and post marketing compliance related issues.
* Plan, conduct and execute assignments, reviewing progress and evaluating results.
* Ensure that all new products are assessed for potential environmental hazards and recommend necessary improvements prior to appropriate design phases per the written procedures.
* Review change control documents directly related to product environmental controls and assist Regulatory with change management assessments.
* Assist in SOP development and review.
* Evaluate regulatory impact of proposed changes to launched products.
* Participate in the development of proposals and solutions to product-associated problems related to PEC.

What you need

* A Bachelors Degree (B.S or B.A) in Science, Regulatory or Engineering, or equivalent focus is required.
* 0+ years experience in QMS, environmental, regulatory or engineering experience
* Excellent analytical and writing skills.
* Effective interpersonal communication skills and organizational skills.