Lead Quality Engineer Apply now » Date:Feb 17, 2025 Location: Tyrone, PA, US, 16686 Company: W. R. Grace & Co. Band Grade : [[5-A]] Annual Wage Range:[[95,000]] - [[105,000]] Other Compensation: Eligibility for the Short-Term Incentive program and other applicable bonuses Benefits:U.S. Employee Benefits Summary (grace.com) (https://grace.com/people-and-careers/benefits/us-employee-benefits-summary/) Final salary and compensation will be based on several factors including candidate qualifications and experience, geographical location, market, and business considerations. Grace, a Standard Industries company, is a leading global supplier of catalysts, engineered materials and fine chemicals. We provide innovative products, technologies and services that our customers use to manufacture everyday products like renewable fuels, pharmaceuticals, toothpaste, cosmetics, food packaging, beer, edible oils and more. Our thousands of employees help shape a better future at our global headquarters in Columbia, MD and locations worldwide. Job Description Lead Quality Engineer The Lead Quality Engineer is an integral member of a dynamic Plant Quality Operations team. The team supports Plant Leadership and stakeholders which enables Grace to achieve and maintain the Quality Management System (QMS). They are an important advisor on regulatory compliance, quality management and contribute to the timely release of products critical to our customers who rely on high quality and outstanding reliability. This is a highly visible role who leads and mentors Quality Specialists and early-career Engineers. They are the primary backup for the Plant Quality Manager and at the forefront of investigations and corrective actions; risk assessment and mitigation are a critical part of their role. By leveraging their continuous improvement mindset, the Lead Quality Engineer will seek out process improvements and innovation. The Tyrone, Pennsylvania Plant manufactures specialty ingredients for emerging pharmaceutical products which target disease such as Diabetes and Nutraceuticals. The Lead Quality Engineer is onsite in Tyrone, PA. Responsibilities + Ensure quality plans are current and suitable change management processes are in place which supports the product and Quality System design. + Lead quality related problem solving and root cause analysis during design and manufacturing. + Collaborate with functional peer groups, including presentations of technical information on specific projects or schedules. + Follow processes and operational policies in selecting methods and techniques for obtaining solutions. + Work on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends. + Lead risk analyses and risk mitigation plans and activities, control plans, and the systems that support. + Oversee processes: trend analysis, assess impact and follow-up (e.g., in QS updates, control plans, competency upgrades, etc.) + Support execution of and complete Quality records review for process documents, pertaining to calibration, validation, environmental controls, training and work instructions. + Support external and regulatory audits, and execute internal audits to assess the effectiveness of the QMS. Required Qualifications + Bachelor’s degree in engineering or related discipline + 5+ years of experience in manufacturing + Demonstrated experience in a regulated industry. + Experience leading project teams across functions and levels and managing competing priorities Physical Requirements and Environment + Must be willing to wear PPE (Personal Protective equipment) including but not limited to hard hat, protective eyewear, steel-toed boots, hearing protection, Level A suit, full face respirator Preferred Qualifications + Continuous Improvement education or experience + Experience with ISO 9001, 21 CFR210/211/820, and ICH Q7. + Experience with Current Good Manufacturing Practices (cGMP) + Aduiting experience including planning, preparation, execution, reporting and follow-up. + Experience with risk management tools and techniques Benefits + Medical, Dental, Vision Insurance + Life Insurance and Disability + Grace Wellness Program + Flexible Workplace + Retirement Plans + 401(k) Company Match – Dollar to dollar up to the first 6% + Paid Vacation and Holidays + Parental Leave (salaried only) + Tuition Reimbursement U.S. Employee Benefits Summary (grace.com) (https://grace.com/people-and-careers/working-at-grace/benefits/us-employee-benefits-summary/) Other Compensation Grace is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Grace via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Grace. No fee will be paid in the event the candidate is hired by Grace as a result of the referral or through other means. Nearest Major Market:AltoonaNearest Secondary Market:Johnstown Apply now » Find similar jobs: