Responsibilities: Essential Duties
- Lead and mentor direct QA and QC reports and their teams.
- Implement and monitor the AIC and AIS Quality Systems and ensure timely reporting of issues to Sr. Management.
- Continually evaluate the company's Quality System compliance status through implementation of internal audits.
- Implement and sustain Risk Management activities in accordance with ISO 14971.
- Prepare Management Review presentations.
- Participate in cross functional teams to ensure a comprehensive Quality Plan is developed for all new products including but not limited to the development of incoming inspection activities.
- Oversee the company's postmarket compliance activities such as complaints, MDRs and recalls.
- Management of Document Control activities, CAPA system, NCMR and, Deviation process.
- Participate/Lead FDA, Notified Body, customer audits, and other external regulators as necessary.
- Oversee the compliance to allograft storage and distribution of human tissue regulations.
- Lead supplier Quality activities such as auditing, monitoring and development and maintenance of quality agreements and supplier file management.
- Develop and manage departmental budgets.
- Ability to travel domestically and internationally (may be up to 20%).
- Must comply with applicable ISO and FDA regulations as stated in Quality Manual
- Must embody the Company's Vision, Mission and Values
- Other duties may be assigned
- Contribute to creating a climate of trust, ethics, and accountability by effectively seeking out and accepting feedback from others.
- Possess the ability to exceed expectations with the customer in mind and take responsibility for driving key results as well as empower others to achieve desired outcomes.
- Demonstrate behaviors that drive efficiency by understanding and improving processes as well as sharing best practices.
- This position will have overall responsibility for the Quality Assurance / Quality Control activities at several Aesculap Inc. and Aesculap Implant System facilities and directly supervise the activities of several manager level and supervisory level Quality Assurance / Quality Control professionals.
- This position is expected to carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Select, train, motivate and develop a highly technical staff with experience in a wide variety of disciplines to accomplish the department's objectives. Responsible for the overall direction, coordination and evaluation of the reporting departments and functions.
Expertise: Knowledge & Skills
- Language Skills: Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management, public groups, and/or boards of directors.
- Mathematical Skills: Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
- Reasoning Ability: Ability to define problems, collect date, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- Bachelor's Degree in Engineering or Life Sciences required; advanced degree preferred
- 15+ years experience in Quality Assurance / Control, Quality Engineering, and Process/Equipment validation programs for medical devices or pharmaceuticals
- A minimum of 10 years experience managing Quality System or Quality Services organization with proven leadership ability
- Strong knowledge of FDA Quality System Regulation, ISO 13485 and ISO 14971
- Successful management of FDA inspections and Notified Body audits and other Regulatory Body interactions
- Experience with human tissue banking regulations preferred
- ASQ or other Quality related certifications in engineering proficiencies (e.g., CQE, CQA, CQM/OE)
- Strong background in statistical techniques, measurement tools and SPC tools; Lean Six Sigma experience preferred
- Proficiency with MS Word, Excel, Power Point and statistical software required
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 30 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.