Bausch Health Quality Systems Engineer III in O'Fallon, Missouri
Career Opportunities: Quality Systems Engineer III (2703)
Requisition ID 2703 - Posted 11/20/2020 - US - O'Fallon - Quality - US - O'Fallon, MO
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company that develops, manufactures and markets a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. Each day, Bausch Health products are used by over 150 million people around the world.
Our approximately 21,000 employees are united around our mission of improving people’s lives with our health care products, and we manufacture and market health care products directly or indirectly in approximately 100 countries.
PURPOSE OF JOB
Ensures Quality System is effective, adequate, suitable, and compliant with appropriate global regulatory requirements.
Partner with Operations leadership (Quality, Engineering, Manufacturing, etc.) to ensure compliance to Synergetics Quality Systems, ISO, and regulatory requirements
Responsible for maintaining a compliant and effective Quality Management System:FDA 21CFR Part 820- Medical Device Quality System Regulation, ISO 13485, EU MDR, and other regulatory standards as appropriate.
Act as Alternate Management Representative.
Manage corporate quality system
Work with management to understand the compliance risks to the business and potential mitigations to those risks
Coordinate, lead, and/or participate in, and/or support FDA, governmental, notified body, regulatory, OEM customer, internal, and supplier audits. Develop appropriate reporting/response as needed.
Manage internal audit program
Ensure proper execution and record retention of quality system documentation and support compliance to quality system requirements
Review and approve quality system documentation as necessary
Track audit nonconformances and drive nonconformances to closure in a timely manner
Manage (directly or indirectly) document control, training, and microbiology functions within Quality Systems group
Participate in CAPA process
Interact routinely with Product Management, Engineering, Production, and Suppliers to proactively improve quality of products
Provide quality and reliability analyses, metrics, and trend reports to Operations and RA/QA management
Generate and approve test protocols, monitor/perform testing, and issue/approve qualification test reports
Participate in design reviews, new product validations, FMEAs and other risk assessment tools as Quality Representative
Provide QS/compliance training to all levels of the organization
Using project management tools and methodologies, lead, facilitate, andcoordinate cross functional teams and projects that assure compliance, and improvement of process, products, customer satisfaction and quality throughout the organization
Ensure utilization of appropriate statistical techniques
Responsible for preparing and hosting Management Reviews
Perform special projects as required by business needs
Must use a collaborative leadership style to successfully achieve objectives
Encourage data driven business decisions by planning and capturing appropriate data and using methodologies for problem solving and analysis
Potentially manage QS responsibilities at multiple facilities
Make presentations on the status of project initiatives to all levels of the organization
Manage and influence those that do not have a direct reporting relationship in order to successfully complete projects and initiatives
Adhere to and ensure the compliance of Synergetics Code of Ethics, all company policies, rules, procedures and housekeeping standards.
Develop and implement trend analysis across all device platforms.
Ensure the promotion and awareness of regulatory and customer requirements throughout the organization
Other duties as assigned.
SUPERVISE DIRECT REPORTS
(yes or no)
SCOPE OF POSITION
Must be team oriented and self-directed
Requires minimum 2 years of experience, preparing and making presentations and managing extensive projects
Must provide attention to detail
Must be flexible to adapt to change in schedule, conditions and working hours
Must have basic knowledge of Microsoft Office, Microsoft Access, and Microsoft Windows
Knowledge and understanding of the US Quality System Regulation (21 CFR Part 820) and the ISO quality management system requirements
Extensive knowledge and understanding of US and international medical device regulations, standards and guidance documents
Excellent oral and written communication skills and people skills
Requires knowledge of problem solving tools to address product and process issues (i.e., DMAIC, Kaizen events, 5 Whys, fishbone diagram, Cause and Effect)
Ability to solve practical problems and deal with a variety of known and unknown variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written,
Considerable responsibility with regard to general assignments, method, manner, and/or sequence of performance of own work.oral, or diagram formats.
Ability to effectively communicate information and respond to questions in person, small group situations and via written format with customers, clients, general public and other employees of the organization.
Contact with other departments with individuals consulting on problems which necessitate judgment and tact in presentation to obtain cooperation or approval of action to be taken.
B.S. in Engineering or field of science, or equivalent experience
ASQ CQA, ASQ CBA, ISO Lead Auditor certification, or prior audit experience required
3-5 years in quality or engineering role
This position may be available in the following location(s): US - O'Fallon, MO
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
Bausch Health is an EEO/AA employer M/F/D/V.