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Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the worldfrom the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our nearly 170-year history. We have a significant global research, development, manufacturing, and commercial footprint of approximately 12,500 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.

Objectives:

Develop and maintain quality systems that comply with applicable B&L and regulatory standards. Supervise the product release, document control functions, training, compliance (internal auditing, supplier management and CAPA), and complaint investigation. Develop and monitor quality improvement and validation activities. Assure compliance to required standards through internal audits and management review, document control system and finish product release. Responsible for communicating and implementing the local quality policy. Special projects and other related duties as assigned.

Responsibilities:

• Ensures that the quality management system requirements are effectively established and effectively maintained in accordance with the requirements of 21CFR820, EU MDR and EN ISO 13485 and reporting to top management on the performance of the quality system for review and any need for improvement.

• Ensures that the processes needed for the quality management system are documented.

• Ensures the promotion of awareness of regulatory and quality management system requirements throughout the organization.

• Assists in developing quality goals and objectives from the Quality Policy that are linked to the business plan. Communicates and implements the Quality Policy.

• Manage Quality System Organization including Document Control, Compliance, and Complaint Investigation functions.

• Assist in the developing and monitoring of quality improvement and validation activities. Overall responsibility for the managing the CAPA system and Management Review process.

• Manages the Internal and External Audit Programs. Liaison with Global B&L and external contacts with regards to quality issues.

Requirments:

• Bachelor's Degree in Life Sciences or Engineering.

• Supervisory experience, minimum 7 years' experience in a regulated medical device or pharmaceutical industry in a quality discipline.

• Medical Devices experience.

• Must have completed three (3) 510(k) submissions and demonstrated ability to prepare submissions independently.

• Experience on Design Control project teams.

• Demonstrated the ability to lead and mentor RA associates regardless of location.

• Demonstrated the ability to make correct decisions based on interpretations of federal laws, which in many instances are very general in nature to accommodate a variety of industries. These interpretations are used for every aspect of the regulatory discipline from submissions to labeling issues.

• Demonstrated the ability to develop global regulatory strategies for high risk products and lead multidisciplinary project teams.

Preferred Q ualifications:

• Advanced ability for independent work, teamwork, and decision making.

• Management experience (at least 5 years project or supervisory management).

• Demonstrated the ability to complete internal update (letters to file) preparations independently and completion of at least five (5).

• Demonstrate the ability to lead complex projects that may include clinical studies.

• Knowledgeable of ISO 13485 and regulatory requirements and quality system development and management.

• Knowledgeable of statistical techniques and application experience.

• Demonstrated project management and leadership skills, strong written and oral communication, and interpersonal skills.

• ISO / QSR training, auditor training , validation experience and applied statistics.

We offer competitive salary & excellent benefits including:

• Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date

• 401K Plan with company match and ongoing company contribution

• Paid time off – vacation (3 weeks - prorated upon hire), floating holidays and sick time

• Employee Stock Purchase Plan with company match

• Employee Incentive Bonus

• Tuition Reimbursement (select degrees)

• Ongoing performance feedback and annual compensation review

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.

To learn more please read Bausch+Lomb's Job Offer Fraud Statement (https://hcm2preview.sapsf.eu/bauschhealT4/Bausch_job_posting_statement.docx) .

Our Benefit Programs: https://www.bausch.com/careers/benefits/

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

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