Director, Quality Management

Location

Vereinigte Staaten von Amerika | Germany

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:

Director, Quality Management

The Director of Quality Management will be responsible for the Quality Management System (QMS) and the communication with certifying and regulatory bodies. The position requires excellent communication skills and the ability to lead employees and customers in the correct and effective use of QMS processes, documentation and reporting.

RESPONSIBILITIES:

• Act as the Quality Representative for the MSEI Quality Management System by overseeing all quality aspects by defining testing standards, strategies, formalizing processes, utilizing best practices, and establishing metrics.
• Define and maintain the MSEI Quality Management System with respect to required standards and regulations.
• Leads internal and external customer audits.
• Implementation of quality monitoring systems and control of component, process and product quality.
• Effective, fact-based risk control in case of incidents.
• Implementation and execution of a periodic Management Review.
• Participation in management and staff meetings related to Quality Management topics.
• Accept other job duties related to the Quality Management System and product quality.
• Continually strive for 100% Right First Manufacturing.

EDUCATION / EXPERIENCE REQUIREMENTS:

• Master degree in Electronic Engineering, Material Science, Mechanical Engineering, Physics or related technical degree(s) required.
• Electronic assembly work experience required.
• Minimum of 10 years of experience in electronic product or medical device manufacturing environment required.
• Minimum of 10 years of experience with ISO 13485 certified Quality Management Systems is strongly preferred.
• Excellent leadership and communication skills (verbal & written), experience in training and mentoring employees.
• Strong team player with multiple levels of stakeholders inside and outside the organization.
• Remains calm under pressure.

ADDITIONAL PREFERRED KNOWLEDGE, SKILLS, ABILITIES:

• Ability to lead teams and influence decisions based on facts and process thinking.
• Ability to build credibility and trust by demonstrating high ethical standards.
• Excellent organizational, interpersonal, and time management skills.
• Excellent verbal and written communication skills that are action oriented and customer service focused.
• SMT assembly experience or electronic component manufacturing.
• Experience with reliability testing and related statistical methods.
• Experience with Manufacturing Execution Systems (MES) and related Business Intelligence Reporting (BI).
• Experience with digital Product Lifecycle Management (PLM) Systems.
• Characterized by a cooperative leadership style at eye level, inner calm and great perseverance.
• Regulatory inspection experience preferred.
• Coach and lead a team effectively.

SUPERVISORSY RESPONSIBLITIES:

• Direct supervision and leadership of Quality Assurance team.

PHYSICAL DEMANDS & WORK ENVIRONMENT:

• Light physical effort for the occasional movement of product or documentation.
• Regularly required to sit, stand or walk throughout the facility.
• This position requires periods of working at a desk and performing tasks on a computer.
• Significant periods of standing or walking throughout the facility to interface with other team members.
• Use PPE appropriately when in the manufacturing environment.

TRAVEL REQUIREMENTS:

Must be able to travel internationally and domestically with estimated travel time less than 20%.

Location: Lake Oswego(0001)

Working hours: Full-time

MSEI Lake Oswego Oregon (US-OR) USA

Job ID: 58605

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.

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