- Establish surgical quality strategy in alignment with Global Quality and Operations strategy and that of surgical business stakeholders.
- Build quality culture in surgical business in alignment with Bausch + Lombs Sustainable Quality Culture and Systems initiatives.
- Together with site Operations leaders, establish annual site Quality Plans and ensure implementation to fulfil strategy with Surgical stakeholders.
- Engage R&D and Design Quality to ensure advanced quality planning and right first time tech transfer for new / enhanced product implementations that ensure right first time launches.
- Utilize metrics (QPIs, KBIs, etc..) and quality science to drive continuous improvement to customers and business results with evidence based decision making.
- Ensure uninterrupted customer supply and approval of new products by maintaining QMS and processes to current global QMS, global standards and regulations, and assuring sustained compliance (VAI or better status at all sites).
- Collaborate with site and functional leadership to drive a Quality Culture across all functions that is based on Effectiveness, Efficiency, and Compliance.
- Ensure strong governance processes are in place to manage systems and provide rapid, transparent escalation and resolution of any issue .
- Site responsibilities include Tree Court, Sovereign Court, and OFallon.
- Create and maintain a highly engaged, knowledgeable, and capable Quality team.
- Bachelors Degree in Technical, Medical, and/or Health Sciences or similar degree.
- Strong Leadership skills with proven record of organization development.
- Comprehensive understanding of U.S. and International regulations and standards for medical devices including 21 CFR 820, ISO 13485, MDR, MDSAP and other applicable standards.
- 10+ years of Quality Assurance or related experience (utilizing quality sciences and regulations) in health sciences industry.
- Minimum 6 years of demonstrable leadership and organizational development role.
- Masters or other advanced degrees related to Medical Device design, development, manufacturing, and or distribution and/or Quality Science (QA, Statistics, Lean Sigma) with management / leadership curricula.
- Quality Management Experience in Software-based Medical Devices with proven track record for driving business results through organization development.
- Proven skills in Lean Sigma or other Quality Sciences strongly preferred. Proven skills in medical device development, preferably including software-based equipment.
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Quality Engineer - St Louis, United States - Bausch + Lomb
Description
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 world-from 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 170-year history. We have a significant global research, development, manufacturing, and commercial footprint of approximately 13,000 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:
Establish quality strategy, and annual implementation plans for surgical devices in collaboration with global Quality and surgical business stake holders, including global commercial leads, R&D, Operations, Regulatory Affairs, and other associated functions. Ensure full product lifecycle management quality systems are implemented and provide oversight for surgical products that ensures customer requirements are defined and delivered in a sustainable, right-first-time system and culture.
Responsibilities:
• 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
*RELOCATION AVAILABLE*
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+Lombs Job Offer Fraud Statement .
Our Benefit Programs:
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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