Quality Manager

TekniPlex•Madison, WI

2d•Onsite

About The Position

TekniPlex is hiring a Quality Manager for our Madison, WI facility. The QA Manager is the appointed Management Representative for Quality with associated responsibilities and authority. This position has the Quality Authority for final disposition decisions of all materials and product. The Quality Manager reports directly to the Quality Director with a dotted line to the Plant Manager and has overall responsibility to make decisions and take action so that quality standards are maintained and continuously improved.

Requirements

BS in engineering, quality, or equivalent work experiences
Minimum 5+ years as Quality Manager or other leadership experience in a manufacturing environment within a regulated industry, or equivalent combination of education and experience
Minimum 3 years of supervisory experience
Minimum 3 years of flexible packaging experience or equivalent preferred
Experience managing eQMS (e.g., Intelex) activities
Previous ISO and GMP experience required, preferably ISO 13485
Knowledge of FDA requirements (21 CFR)
Medical device experience is a plus
Strong computer skills: Microsoft products (Excel)
ERP and other planning software
Minitab
Basic understanding of quality equipment, instruments, and processes
Strong communication and interpersonal skills (internal and external)
Must have the ability to develop and lead an accountable team
Strong negotiation and conflict resolution skills
Strong attention to detail
Must be self-motivated
Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals.
Ability to write routine reports and legibly complete time cards and work orders.
Ability to read, analyze, and interpret technical procedures and read blueprints and technical drawings, such as machine, mechanical, pneumatic, hydraulic, and electrical.
Ability to effectively present information in one-on-one and small groups situations to other employees of the organization.
Ability to effective present information and respond to questions form groups of managers, clients, customers, and the general public.
Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals.
Ability to compute rate, ratio, and percent.
Ability to apply concepts of basic algebra, geometry, fractions, percentages, ratios, and proportions to practical situations.
Ability to solve practical problems and deal with a variety of variable in situations where only limited standardization exists.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form.
The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 50 pounds.

Nice To Haves

Medical device experience is a plus

Responsibilities

Manage site’s Quality Management System using Intelex (eQMS software)
Responsible for complaint management, nonconformances, training management, document control, change management, supplier management, audit management, calibration
Evaluate KPIs by completing monthly and annual KPIs
Drive improvements to ensure compliance to site’s quality objectives
Responsible for assuring products meet internal and external quality requirements
Coordinate Corrective Action activities
Selection and maintenance of tools, inspection systems, and associated equipment
Responsible for oversight of supplier quality, including supplier approval, complaints, and audits.
The evaluation and review of quality requirements
Communication with customers regarding complaints, change control, etc.
ISO Management Representative; Responsible for QC participation/compliance with GMP and other programs.
Participate in cross-site internal audits of other TekniPlex Healthcare locations
Plan, host, and coordinate Internal, Customer, and annual ISO 13485 audits
Supervisory oversight of quality team including performance management
Responsible for participating in the facility’s Safety and Environmental programs to ensure a safe work environment.
Promote worker safety by: Actively assesses activities on a constant basis to ensure no unsafe actions or results will occur. Stressing safe working practices as a condition of employment to associates. Leading audit initiatives of employee behaviors to ensure compliance with safety rules and guidelines, as well as housekeeping audits and surveys. Ensuring the housekeeping in the facility is maintained or improved to the highest level possible. Ensuring that all corporate initiatives are followed as appropriate
Ensures Quality products and processes are maintained by: Understanding and supporting both quality policies and the Quality System. Performing work at a level that ensures quality of this position’s work meets or exceeds internal and external customer specifications. Identifying and correcting, where possible, any identified quality issues throughout the plant. Development and implementation of quality training. Participating in system or quality-based training provided or recommended by the company
Actively participates in the continuous improvement process by: Identifying and addressing any opportunities to reduce cost, improve product repeatability & reliability Lead and or champion CI teams to eliminate problems, streamline operations or other areas as defined by management
All other duties as assigned.