Quality Engineer - Manufacturing

B. Braun Medical, Inc.

Company: B. Braun US Device Manufacturing LLC

Job Posting

Location:

Allentown, Pennsylvania, United States

Functional Area: Quality

Working Model: Onsite

Days of Work: Wednesday, Tuesday, Thursday, Friday, Monday

Shift: 5X8

Relocation Available: No

Requisition : 8695

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 us on the internet.

Provide full quality support and expertise to others to achieve a high level of quality material, product, process, and test methods. Managing and performing root cause analysis and investigation studies for nonconformances, CAPAs and complaint trends. Serve as QA representative for material review board (MRB) meetings. Owner and execute quality improvement change controls. Provide risk assessment and an accurate action plan/solution that immediately mitigates impact on Quality and Production KPIs.

Lead and execute equipment installation, qualification, and test method validation activities.

• Establishes quality standards for products and processes and suggest modifications meant to prevent defects in components or final products.
• Works closely with cross functional teams, including product design, product management and production, to identify and mitigate quality risks.
• 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.

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

• 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 primarily with department supervisors, leads, subordinates, and peers. Occasional contact with external contractors/vendors.

Required:

• 2-4 years related experience required
• Bachelor's Degree required

Desired:

• Applicable industry/professional certification preferred.

• Occasional business travel required
• Attendance Requirement Regular and predictable attendance

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.

• Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.

Lifting, Carrying, Pushing, Pulling and Reaching:

• Occasionally:
  Reaching upward and downward, Push/pull
• Frequently:
  Stand, Sit
• Constantly: N/A

Activities:

• Occasionally:
  Finger feeling, Handling, Hearing - ordinary, fine distinction, loud (hearing protection required), Push/pull, Reaching upward and downward
• Frequently:
  Sitting, Standing, Talking - ordinary, loud/quick, Walking
• Constantly: N/A

Environmental Conditions:

• Occasionally:
  Proximity to moving parts
• Frequently: N/A
• Constantly: N/A

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

$85,300 - $95,300

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement.

All qualified applicants will receive consideration for employment without regard to race, color,…