Manager, Quality Position Available In Miami-Dade, Florida

Manager, Quality Thermo Fisher Scientific – 3.4

Miami, FL Job Details Full-time Estimated:

$95.4K – $126K a year 10 hours ago Qualifications Management Bachelor of Science

GMP ISO 9001

Complaint handling 3 years Six Sigma Bachelor’s degree Continuous improvement Manufacturing Senior level Leadership Communication skills

ISO 13485

Full Job Description Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP)

Safety Standards, Cleanroom:

no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc… allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Quality Manager is responsible for coordinating oversight and compliance of quality systems within the site while aligning leaders to meet business needs. Models our 4i values, integrity. Innovation, intensity, and involvement. Follows our Quality Policy by continuously improving the quality of our products & services and by ensuring global regulatory compliance.

Essential Functions:

Maintain proven understanding of Quality System Requirements (ISO 9001, ISO 13485, CFR 820) Responsible for: customer complaints, quality metrics, management reviews, audit program, regulatory compliance, quality holds, customer notifications, market corrections or withdrawals, Nonconformances and CAPA system, quality support for Design Control and New Product Introduction, Change Control, Customer requests and interactions (C of As, Quality Surveys, Quality Agreements). Lead supporting quality sub teams through training, development and feedback. Accountable for the management of Quality Systems initiatives for the site, business unit, division, or group, through a matrix organization. Drive initiatives as established by the Sr. Quality Systems Manager encompassing the Business Leaders and Quality teams. Collaborate effectively with internal and external team members and partners. Ensure the businesses supported remain aligned with local, federal, and business rules and regulations with an emphasis on Computer System compliance. May be required to perform other related duties as the need arises and/or assigned. Knowledge and Experience A Bachelor of Science in a technical field. 3-5 years leadership experience required 7 years experience in a regulated industry such as pharma and/or medical device manufacturing. Experience and awareness of Continuous Improvement, Lean and Six Sigma methodologies. Experience with NC/CAPA system, Change Control, New Product Introduction, Customer requests and complaint management preferred. Experience with leading and hosting internal and external audits. Skills Models strong leadership, personal accountability, integrity, and operations excellence Ability to work in a matrix environment, applying influence. Excellent verbal and written communication skills, comfortable in an executive and manufacturing environment. Ability to handle conflict with confidence and integrity. Proven experience in forming, developing and maintaining an impactful team. Sound interpersonal skills and a keen ability to multi-task in a detailed environment.