Quality Engineer I

B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap and CAPS.

Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.bbraunusa.com

Position Summary: This role supports quality oversight of supplier-related activities for externally sourced finished goods for both medical devices and pharmaceuticals. This role ensures supplier-provided finished goods meet regulatory, quality and safety standards and supports supplier-related quality processes across the product lifecycle.

Responsibilities: Essential Duties

• Establishes quality standards for products and processes and suggest modifications meant to prevent defects in components or final products.
• Audits production processes, raw materials or suppliers/vendors to ensure that established quality standards are met.
• Conducts root cause analysis for defects, non conformities or other quality failures.
• May be responsible for ensuring compliance with formal external quality standards, such as ISO 9001.
• Support investigations of supplier-related non-conformances, deviations and complaints.
• Support root cause analysis and implementation of corrective and preventive actions ( CAPAs and SCARs) related to supplier issues.
• Act as the quality subject matter expert on new product introductions including review of product lifecycle documentation such as but not limited to verification and validation documents, risk analysis documents, labeling, product test specifications and inspection and release documentation.
• Review supplier change notifications as a quality subject matter expert and ensure changes are appropriately evaluted for risk and quality impact.
• Ensure compliance with applicable regulations and standards (FDA 21CFR Part 820, 210/211, ISO 13485, ISO 14971)
• Works closely with cross functional teams, including product design, product management and production, to identify and mitigate quality risks.

Expertise: Knowledge & Skills

• Requires full working knowledge of relevant business practices and procedures in professional field. Uses standard theories, principles and concepts and integrates them to propose a course of action.
• Works under general supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, assigning & checking the work of other peers.
• Judgement is required in resolving all day-to-day problems.
• Contacts are with external contractors/vendors, department supervisors, leads, subordinates, and peers.

Required:

• Bachelor's degree required.
• 2-4 years related experience required.
• Applicable industry/professional certification preferred.
• Regular and predictable attendance
• Occasional business travel required, Secrecy and invention agreement and non-compete agreement, Ability to work non-standard schedule as needed

$80,000 -$90,000

#LI #AL

The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.

Through its "Sharing Expertise" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here.