With a nationwide sales team and several manufacturing locations, B. Braun Medical has become a leading full-line supplier of healthcare products and services in the U.S. The company is committed to delivering innovative products and services with unmatched quality, superior technology, and cost-effectiveness, while maintaining environmental responsibility. Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. B. Braun employs over 4,500 people in the USA. B. Braun Medical Inc. began its operations in the USA in 1957. Initially, the company manufactured and sold disposable plastic syringes. During the 1980s and early 1990s, the company undertook several expansions and enlarged its product line of disposable medical devices. With the acquisition of McGaw, Inc. in 1997, including Central Admixture Pharmacy Services, Inc. (CAPS®), B. Braun dramatically broadened its product lines and services to U.S. customers.
U.S. Facilities and Operations:
Supporting product sales are a network of nationwide marketing and manufacturing locations. Bethlehem, Pennsylvania, is home to the U.S. Corporate Headquarters along with the marketing offices of the Hospital, Outpatient Markets (OPM), Renal Therapies, Vascular Interventional, International, and OEM Divisions. Central Admixture Pharmacy Services, Inc.(CAPS®) is also managed from this location. The nearby Allentown, Pennsylvania, facility manufactures Needle-free products, IV Safety Catheters, Anesthesia Systems, Introducers, Pharmacy Admixture products. Vascular products including Right Heart Catheters and Interventional Accessories are also manufactured in Allentown. The Irvine, California facility produces IV Solutions, Basic and Specialty Nutrition, Drug Delivery, and BTC products. Infusion Pump Systems are manufactured in Carrollton, Texas and IV administration and IV and Irrigation sets are produced in the Dominican Republic.
Provide technical expertise and specialized knowledge in CAPA, Complaint Investigation, Risk Management, Validation, Operation support, Supplier Quality and Quality Control Systems for the medical device manufacturing and servicing processes and related products. Provide Quality Assurance support toward design, development, validation, and maintenance of products, processes, equipment, and facilities.
Responsibilities: Essential Duties
- Prepare and present technical investigative reports to first level management. Formulate recommendations for disposition or other actions related to product non-conformances and field performance issues.
- Coordinate, review and approve investigations related to: customer complaints, process discrepancies (DSMS, OOT, etc.), CAPA, audits, supplier investigations and escalation to recall committee, as needed. Work with technical functions to ensure thorough and accurate investigations.
- Ensure that complaint files are maintained per company policies and procedures. Communicate product complaint information internally with sales force, marketing functions, and operations, and externally with customers and regulatory bodies, where required, both verbally and in writing.
- Track and trend data from all quality data sources for CAPA input and continuous improvement. Prepare trend reports for management.
- Support timely data entry into complaint database. Assess individual complaints for regulatory reporting requirements. Assure that regulatory reports (MDR or MDV) are filed as required.
- Ensure appropriate decision making around resolving customer issues during service (to ensure actions are not reportable).
- Oversight of servicing activities including failure analysis trending.
- Provide leadership and technical decision making for management and high level technical personnel regarding cGMP compliance, regulatory issues, validation strategy, and quality systems for projects and/or strategic activities.
- Operate in accordance with company policies and procedures, FDA Regulations, ISO Standards and Canadian Medical Device Regulations, where applicable.
- Participate in preparation, review and approval oversight of Risk Analysis, Health Hazard Assessments or any type of product Risk Management as applicable.
- Create/update QC procedures for DMR or for the Quality System as needed.
- Identify and validate test methods.
- Create and Negotiate Quality Agreements.
- Ensure statistical sampling plans.
- Participate, review and assess Change Controls and Design Control items.
- Review and approve DMR, Design History File, protocols and reports (design verification, design validation, process validation).
- Review and approve BOMs, drawings/labeling (new/modified), specifications
- Participate in Design Reviews.
- Participate and provide input to Validation Plans and Software/Hardware Validation Protocols for new and existing medical device products. Assist in the design and validation of new and existing medical device products.
- Facilitate configuration control boards for hardware and software.
- Support supplier and material certification programs.
- Provide guidance to peers and subordinates within the Quality Assurance organization and interface with first-level management as well as personnel from Engineering, Operations and other technical disciplines.
Expertise: Knowledge & Skills
- Experience in US FDA GMP, ISO standards, as well as, comparable international regulatory agency requirements for quality control in medical device operations.
- Familiarity and understanding of technical disciplines related to Quality Control, Quality Assurance and Validation, including Engineering and Software Development.
- Understanding of medical product lifecycle process and design
- Understanding of product reliability under a medical device service environment.
- Ability to investigate and analyze technical and regulatory issues.
- Understanding of Risk Management for medical devices per FDA and ISO14971
- Ability to design, execute, and analyzes industrial experiments and process capability studies.
- Ability to prepare, execute and analyze process validation studies.
- Ability to prepare and execute validation plans for medical device product manufacturing equipment and facilities.
- Ability to understand and execute corrective/preventive activities related to validation, product and process control.
- Ability to act effectively as a member of a team to resolve problems.
- Ability to simultaneously work on several projects with the flexibility to reprioritize in a minimum amount of time.
- Strict attention to detail required. Problem detection ability.
- Excellent written and oral communication skills, interpersonal skills and problem-solving skills.
- PC skills to include MS Office Software packages supporting statistical data analysis, word processing, and project management.
- Statistical analysis to include basic descriptive statistics and standard error of the mean
- Project management skills to run smaller projects, including the use of MS Project.
Expertise: Qualifications - Experience/Training/Education/Etc
- Bachelor's Degree in a scientific or technical discipline
- Minimum 4-5 years experience in a Quality Assurance/Engineering position with 2 years computer system/software validation experience.
- At least 3 years experience in a Medical Device manufacturing Quality Control or Engineering position.
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.
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 Equal Opportunity Employer Minorities /Women/ Veterans/Disabled
Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.