Quality Engineer II - QC analytical laboratory and Sterilization

About B. Braun

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:

Provide full quality support and expertise to others with the focus of Quality testing Laboratories to achieve a high level of quality material, product, process, testing instrument, and methods. Managing and performing root cause analysis and investigation studies for out of specification and out of trend results. Serve as QA representative for material review board (MRB) meetings. Owner and execute laboratory 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 method validation activities.

Responsibilities: Essential Duties

• Establishes quality standards for products and processes and suggest modifications meant to prevent defects in components or final products within the organization's Distribution Centers.
• Assists with execution of tasks associated with warehousing and distribution, including quarantine, storage under appropriate conditions, stock rotation, & inventory management.
• Works closely with cross functional teams, including product design, product management and production, to identify and mitigate quality risks.
• Audits logistics processes, including all aspects of holding and distribution, in accordance with applicable procedures and regulations, 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.

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

General:
It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons.

Expertise: Knowledge & Skills

• Requires full working knowledge of professional field and industry.
• Influences the development of and drives the application of principles, theories, concepts.
• Determines best course of action.
• Work under general supervision.
• Relies on experience and judgement to plan and accomplish assigned goals.
• May periodically assist in orienting, training, assigning and checking the work of lower level employees.
• Referring only complex problems and issues

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.

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Expertise: Qualifications -Education/Experience/Training/Etc

Required:

• Bachelor's degree required.
• 05-06 years related experience required.
• Applicable industry/professional certification required.
• Regular and predictable attendance
• Occasional business travel required, Ability to work non-standard schedule as needed

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.

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Responsibilities: Other Duties:

The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.

Physical Demands:

While performing the duties of this job, the employee is expected to:

• 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, Stand
• Frequently:Sit
• Constantly:N/A

Activities:

• Occasionally:Push/pull, Reaching upward and downward, Seeing - depth perception, color vision, field of vision/peripheral, Standing, Walking
• Frequently:Finger feeling, Hearing - ordinary, fine distinction, loud (hearing protection required), Sitting , Talking - ordinary, loud/quick
• Constantly:N/A

Environmental Conditions:

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

Work Environment:

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.

• Noise Intensity:Moderate
• Occasionally:Warehouse environment
• Frequently:Office environment, Production/manufacturing environment, Lab environment
• Constantly:N/A

Equal Opportunity Employer Veterans/Disabled

PI254594081