Job Description

WHAT IS TEKNIPLEX?



TekniPlex Healthcare leverages its world-class materials science knowledge to deliver better patient outcomes by designing and manufacturing products that allow for less invasive procedures, reduce pain, enable faster healing and safer drug delivery.



We harness the power of world-class materials scientists, a global network of application-specific engineers, and healthcare technical teams to provide today's finest materials solutions.



We work in a collaborative and consultative way with our customers to develop the ideal material solution to optimize mechanical properties and chemical composition to achieve the desired product performance. We are currently hiring a Quality Supervisor for our Madison, WI facility.



JOB SUMMARY



Ensure the highest standards in accordance with regulatory and customer requirements. Work directly with the quality assurance technicians on product evaluations during the production process. Analyzes the data from inspection reports and resolve quality problems as they are revealed through inspection procedures. Ensures that the production department has audits of the processes and parts.



DUTIES AND RESPONSIBILITIES


This job will be responsible for supervising QA technicians whose tasks range from inspection, assessment, verification/testing, and documentation of process and product quality on all goods, incoming goods, in-process used in the manufacture of our product and finished goods to the customer and acceptability thereof Included in these duties are instrument care, calibration and documentation Responsibilities include hiring, interviewing, training, reports, scheduling Promotes personal and product safety by: + Constantly accessing job requirements and addresses possible job hazards by either eliminating the hazard or through implementing a requirement for PPE or possible engineering solution
+ Audits employee behaviors to ensure compliance with safety rules and guidelines
+ Drive floor level safety compliance and implement safety initiatives
+ Participates actively on the plant-wide safety teams
+ Leads daily activities of quality area to ensure that volume, safety, and quality standards are achieved
Act in conjunction with Quality Assurance Manager, as a technical contact, on quality related issues for internal and external customers On site assistance for Audits including, but not limited to Safety, Supplier, ISO, Internal, and External Assist in timely response to customer complaints, including Root Cause and Corrective Action (RCCA) Direct or Assist Corrective Action Request (CAR) process Develop and implement Good Manufacturing Practices (GMP) and other quality process training Drive continuous improvement and stays current with industry best practices Aid in development and implementation of Quality System Documentation and its maintenance Fully support and work with every department, cross function team, intra-departmental team in quality related issues Apply root cause analysis and problem-solving techniques when addressing customer concerns Coordinate any measure process improvements of the quality measurement systems Coordinate and monitor quality technicians' daily activities, channeling the fulfillment of their goals Apply Lean Manufacturing and Six Sigma principles Generate process flow maps /diagrams, control plans and measurement system evaluations to support standard requirements Technical assistance in audits by third party registrars/customers Investigate and document customer non-conformances and corrective actions Support all the activities related to the implementation and maintaining the ISO 13485 procedures and work instructions Lead or support Validation projects for new products, Transfers, validation changes and revalidation Support documentation review and batch release Manage and maintain training matrix Perform training to QA technicians and Plant staff regarding Quality system documentation Prepares routine reports - including gathering and summarizing data (i.e. preparing manufacturing standards to be released to the production floor and C of C's for product release) Actively participate in the continuous improvement process (CIP) by identifying and addressing opportunities to reduce cost, improve the product/ process/ documentation/ procedures and/or the overall operation and participate in CIP teams to eliminate problems, streamline operations or other areas as defined by management Other duties as assigned

REQUIRED QUALIFICATIONS

Must have a Bachelor degree, preferably in Production or Industrial Engineer experience or equivalent combination of education and experience 2+ years of working experience Six Sigma training and / or certification is a plus

LANGUAGE SKILLS



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.



MATHEMATICAL SKILLS



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.



REASONING ABILITY



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.



PHYSICAL DEMANDS



The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.



While performing the duties of this job, the employee is regularly required to stand, walk, and talk or hear. The employee frequently is required to use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to sit; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.



WORK ENVIRONMENT



While performing the duties of this job, the employee is frequently exposed to moving mechanical parts and vibration. The employee is occasionally exposed to high, precarious places; fumes or airborne particles; toxic, flammable or caustic chemicals; outside weather conditions; and extreme heat. The noise level in the work environment is usually moderate



The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.



Equal Opportunity Company



Tekniplex is proud to be an Equal Opportunity Employer. Our hiring practices provide equal opportunity for employment without regard to race, religion, color, sex, gender, national origin, age, United States military veteran's status, ancestry, sexual orientation, marital status, family structure, medical condition including genetic characteristics or information, veteran status, or mental or physical disability so long as the essential functions of the job can be performed with or without reasonable accommodation, or any other protected category under federal, state, or local law.



Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.