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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.

OBJECTIVES/

PURPOSE OF JOB

Ensures Quality System is effective, adequate, suitable, and compliant with appropriate global regulatory requirements.

KEY ACTIVITIES/

RESPONSIBILITIES

  • 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)

Yes

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.

KEY RELATIONSHIPS

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.

QUALIFICATIONS/

TRAINING

Required Education:

B.S. in Engineering or field of science, or equivalent experience

Preferred Education:

Required Skills/Qualifications:

ASQ CQA, ASQ CBA, ISO Lead Auditor certification, or prior audit experience required

Preferred Skills/Qualifications:

Required Experience:

3-5 years in quality or engineering role

Preferred Experience:

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.

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Bausch Health is an EEO/AA employer M/F/D/V.

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