Staff Quality Engineer

Drägerwerk AG & Co. KGaA; Telford; Hybrid; Confidential; Full time

Job summary

A leading company in medical technology is seeking a Staff Quality Engineer to provide quality leadership for product development activities. This hybrid role requires expertise in FDA regulations and strong communication skills. Join a team committed to enhancing patient safety and product quality.

Benefits

Comprehensive medical, dental & vision coverage

Paid time off starting at 4+ weeks per year

Tuition reimbursement

401k match

Wellness and employee support programs

Life insurance

Free parking

Onsite gym with fitness instructors

Full-service cafeteria

Game room at select locations

Qualifications

• 8-10 years of experience in a related discipline.
• Medical Device experience preferred.
• ASQ Certification(s) as a Quality Engineer, Quality Auditor, etc.

Responsibilities

• Evaluate and process medical devices warranties and failures.
• Conduct initial investigations related to product failures.
• Assure compliance to applicable processes during New Product Development.

Skills

Root-cause determination

Statistical methodology

Strong communication

Teamwork

Leadership

Education

Bachelor’s degree in a technical discipline

Tools

FDA Quality System Regulations

ISO 9001

ISO 13485

MDR

Job description

The Job Responsibilities

We’re hiring! If you want your contributions to make a real difference, check out this new career opportunity with us atDraegerwhere we are led by the guidingprinciple “Technology for Life”.

The Staff Quality Engineer is a hybrid position (3 days in office) located at our North America headquarters in Telford Pennsylvania.

The Staff Quality Engineer provides quality leadership for sustaining and new product development activities of medical device products. Ensures that all applicable regulatory standards and directives are applied and managed in Draeger Medical Systems Incorporated (DMSI).

Key Responsibilities

• Evaluating and processing medical devices warranties and failure on arrivals.
• Conducting initial investigation related to product failures and root-cause determination.
• Assure that Cross Functional Teams (CFT’s) comply to applicable Draeger processes and procedures during Design and Development phases of New Product Development (NPD) for Draeger Medical Systems, Inc.
• Review and approve NPD deliverables as defined in the Design and Development Plan.
• Develop the Quality Plan portion of the Design and Development Plan.
• Assure CFT’s meet Design and Development Plan deliverable timelines by periodically auditing the DHF (Design History Files).
• Coordinate with and provides guidance to other Quality Assurance related functions (supplier, manufacturing, lifecycle) to assure that any manufacturing and/or field nonconformance are properly captured in the appropriate internal process to prevent recurrences. Coordinates and monitors improvement measures and CAPAs.
• Coordinate, together with the CFT, a Health Hazard Evaluation when a product malfunction or deficiency indicates a potential patient/user safety risk.
• Review and approve Deviations requests to assure that safety and quality requirements are maintained. Prepare and recommend Production Holds/Ship Holds to assure that known product deficiencies do not reach the end customer.
• Authors, reviews and / or approves and provides training fo: QMS procedures and documentation; Deviation Permits: Ship Holds, Technical Service Bulletins, and other documentation as required.Performs other duties as needed and assigned (i.e. conduct audits, etc.)

Your Qualifications

• Bachelor’s degree in a technical discipline or the equivalent in education, training and related experience.
• 8 -10 years of experience in a related discipline.
• Root-cause determination and solution recommendation through applied statistical methodology.
• Medical Device experience preferred.
• ASQ Certification(s) as a Quality Engineer, Quality Auditor, etc.
• Expertise in FDA Quality System Regulations (21 CFR Part 820), ISO 9001, ISO 13485, MDR
• Strong communication, teamwork and leadership skills.
• A self-starter that is part of the solution and results oriented.

The Dräger Workplace

Draeger has several sites located across North America as well as field-based sales and service positions. Our North America headquarters is located in Telford, PA just north of Philadelphia. We also have US sites in Andover, MA, and Houston, TX. Our Canada site is located in Mississauga, Ontario.

Employees at our Houston, Texas facility are responsible designing comprehensive customer solutions leveraging our Safety portfolio which includes essential lifesaving products including portable gas detection, Draeger Tubes and SCBAs.

EEO is the Law

Draeger is an Equal Opportunity Employer. To learn more:Know Your Rights: Workplace Discrimination is Illegal (dol.gov)

Who we are

From hospitals to fire departments to industrial customers, people around the world rely on our products: cutting-edge technology that combines real engineering with the digital future. With over 130 years of experience, passion and the bold ideas of more than 16,000 employees, we are committed to turning technology into ›technology for life.

Benefits
Dräger is responsible for life. The lives of our employees are especially important to us, therefore, Dräger believes in fostering a culture that places the focus on employee health & wellbeing, both in the office and at home. We offer a generous benefits package that includes, comprehensive medical, dental & vision coverage, paid time off starting at 4+ weeks per year, tuition reimbursement, 401k match, wellness and employee support programs, life insurance and more. Dräger also offers localized perks such as free parking and onsite gym with fitness instructors and classes, full-service cafeteria, and game room at select locations.