Quality Investigator; Mon - Fri

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

Provide support to the functional groups within the company on proper investigations maintaining standard work through the utilization of trend analysis, lean manufacturing principles, engineering studies, process and test method development and validation and statistical process control. Investigations include DSMS, Product Complaints, Internal and External audits, Process verifications performed by QC Process Control, Reserved sample discrepancy. Interface effectively with Quality Assurance, Engineering, Manufacturing, Regulatory Affairs personnel and other technical functions.

Conduct impact assessments for process deviations and discrepancies, including Out of Tolerance (OOTI) calibration reports. Conduct and support investigations of manufacturing nonconformities and recommend, develop and implement effective corrective actions. Ensure that investigations are thorough, accurate and being conducted in a timely manner. Ensure that Discrepancy files are properly maintained in accordance with company policies and procedures.

Assure that controls are in place to effectively and accurately process Discrepancies. Serve as a Quality representative to improve awareness, visibility and communication on quality initiatives to support departmental, functional, facility and corporate quality goals and objectives. Serve as primary contact for investigation support of the QO/QA department.

Responsible to create, follow up and drive QCRV to the completion. Review and maintain the closed QCRV documents to ensure it meets the compliance standard requirements.

• Perform quality investigations for non-conformances by reviewing data, master history records, and interviewing personnel.
• Obtain information from SMEs, publications, manuals and other sources.
• Complete the investigation write-up.
• Present investigation results to Quality Management.
• Write and conduct quality protocols as required.
• Review quality records.
• Conduct timely quality review of associated data and documents to support batch release, to meet business and operations requirements.
• Assist in complying with regulatory requirements related to product safety and quality.
• Oversee quality operations system (i.e., QCRV, IR, Process Verification, etc.).

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

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.

Required:

• Requires basic 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, and/or reviewing the work of other peers.
• Judgement is required in resolving all day-to-day problems.
• Contacts are primarily with direct supervisor, peers and subordinates. Expertise:
  Qualifications
  -Education/Experience/Training/Etc
• Bachelor's degree required or equivalent combination of education and experience.
• 02-04 years related experience required.
• Applicable industry/professional certification preferred.
• 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.

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,…