This leadership role in Quality Assurance requires the manager to lead the oversight and integrity of Quality systems for Bausch + Lomb devices within the St. Louis site. The individual represents site management quality systems and establishes appropriate standards and guidelines to ensure lasting customer satisfaction.
Supports the development and maintenance of quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to establish standards and agency guidelines.
Reviews, analyzes and reports on quality discrepancies related to products manufactured at site and works closely with various key functions to develop disposition and corrective actions for recurring discrepancies.
Works with site management to develop management control requirements and facilitates aspects of management review, complaint review board and compliance requirements based on North American Quality System requirements.
Report on the status of the Quality System to the St. Louis site management team.
Develops quality goals and objectives linked to the business plan and ensures cascading of such objectives within their function.
Evaluate, analyze and report on product and process quality performance to established quality goals. Monitor product quality through inspection testing and auditing. Establish statistically sound programs for sampling and process validations
Liaison with Regional functional contact points regarding site quality issues. Support the needs of other departments with their quality improvement efforts.
Document creation/change control and quality records management.
Management of the CAPA system
Management of internal compliance program.
Establish and monitor environmental control, microbiological parameters, sterilization validation and monitoring methods, where applicable.
Ensure employees are trained on the Quality Policy, Quality Objectives, and quality concepts/tools.
Product complaint evaluation and analysis
Define and implement quality improvement plans based upon customer feedback.
Management of internal (e.g. Corporate) audits and external (e.g. FDA, EU Notified Body, TUV, ETL, & CSA) inspections.
Supervises employees in the Quality, Receiving, In-Process Inspection and Product Final Release, Document/Change Control, Calibration, Process Validation, Software Quality Assurance (SQA), Compliance (internal auditing, external auditing, supplier management and CAPA), Complaint Evaluation and Sterility Assurance.
Responsible for the overall direction, coordination, and evaluation of these units. Also directly supervises four non-supervisory employees.
Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Position manages Quality Engineering function in St. Louis. Team consists of Value Stream Quality Specialist, Engineers and technicians as well as Document control (10 total).
Position will be responsible for manufacturing quality, Complaint and NC management and CAPA, Validation, and Change control for both St. Louis facilities.
Bachelor's degree in a Technical discipline from a four-year college or university
Master's Degree Preferable
Language Skills - Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Mathematical Skills - Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Reasoning Ability - Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Ability to direct and lead individuals at all levels of the organization in achieving a world class Quality System
A minimum of 10 years’ experience, with 5+ years in management role working in the Quality Assurance field, as well as, experience working with FDA and EU MDD Quality System Regulations.
Certificates, Licenses, Registrations
American Society for Quality (ASQ) Certification