Quality Assurance Engineer at BIOTRONIK, Inc. in Lake Oswego, Oregon

Job Description:

Working for Micro Systems Engineering, Inc. (MSEI) means joining an elite team to work on some of the most exciting challenges in medical technology today. We are a pioneer in developing innovative implantable medical device technologies and devices that save and enhance the quality of life for millions of individuals living with cardiovascular and chronic neurologic pain disorders. With more than 40 years of experience in design and manufacturing of active implantable medical devices, our continuing success is based on our company's core values - innovation, quality, reliability, integrity, teamwork, and undisputed expertise - thus enabling us to inspire confidence and trust in physicians and patients worldwide. We are continually looking for talented engineers, scientists, and professionals to share in our mission.

Please join us as:

We are expanding our operations team and seeking a skilled Quality Assurance Engineer to manage and continuously improve our Quality Management System (QMS). In this role, you will collaborate with cross-functional teams to enhance product quality by establishing and implementing protocols aimed at minimizing or preventing defects. You will be responsible for driving activities related to early issue detection, product containment, root cause analysis, and implementing corrective and preventive actions in response to quality excursions. Additionally, you will lead efforts related to data traceability, reporting, and communicate directly with customers and suppliers regarding quality issues or change management processes. The ideal candidate will demonstrate strong interpersonal communication skills and have the ability to lead employees in the effective use of QMS in compliance with ISO 13485 standards.

Your Responsibilities

• Takes ownership of Quality Management Systems related to product identification and traceability, customer feedback, Corrective and Preventive Action (CAPA), monitoring and measurement of product, management of nonconforming product, and quality audits.
• Corresponds directly with customers on quality-related information and data.
• Supports the manufacturing implementation of new products into, representing quality as part of the new product introduction.
• Identifies opportunities to improve and sustain product quality and process effectiveness.
• Prepares training material and conducts training sessions on improvement tools.
• Reports to all levels of the organization on the status of projects and improvement goals.
• Assists in supporting external audits and ensures timely response to documentation requests for auditors.

Your Profile

Education / Experience Requirements

• Bachelor's or higher degree in EE, Physics, Mechanical Engineering, Material Science, Chemistry or related technical disciplines.
• Familiarity with defects found in high reliability electronic assemblies.
• Knowledge of data retrieval and statistical analysis methods.
• Strong verbal, written, organizational, time management and interpersonal skills.

Additional Preferred Knowledge, Skills, Abilities

• ISO 13485 or related Quality Management Systems in a medical regulated environment.
• Electronics manufacturing experience.
• Experience in training systems (LMS).
• Statistical analysis of data.
• Strong computer skills.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this job, the employee is regularly required to be independently mobile.
• The employee is also required to interact with a computer for extended periods of time, and communicate with co-workers.
• Must be able to work a minimum of 40 hours / week.
• Must be able to travel to other office locations.

Location:

Job ID:

Micro Systems Engineering, Inc. is an equal opportunity employer. In accordance with applicable law, the company prohibits discrimination based on race, color, religion, creed, gender, pregnancy or related medical conditions, age, national origin or ancestry, physical or mental disability, sexual orientation, genetic information, uniformed service or any other consideration protected by federal state and local laws. Our commitment to equal opportunity employment applies to all persons involved in our operations and prohibits unlawful discrimination by any employee.

Micro Systems Engineering, Inc. believes that diversity leads to strength.