Senior Quality Engineer bei TekniPlex

WHAT IS TEKNIPLEX?

TekniPlex Healthcare is a respected business partner that specializes in the manufacturing of medical and pharmaceutical packaging for companies around the world. We aim to deliver better patient outcomes by manufacturing products that allow for less invasive procedures, reduced pain, faster healing, and safer drug delivery. We are currently hiring for teammates in our Quality Department, located in Madison WI.

JOB SUMMARY

The Sr. Quality Engineer will be responsible for ensuring product and process quality across manufacturing operations in accordance with internal standards and external regulations (e.g., ISO 13485, FDA). This individual will drive continuous improvement initiatives, support quality system management, and work cross-functionally to resolve issues and maintain compliance.

DUTIES AND RESPONSIBILITIES

• Quality Systems & Compliance:
• Support the development, implementation, and maintenance of the Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, and customer-specific requirements.
• Participate in internal and external audits (e.g., FDA, ISO, customer).
• Process & Product Quality:
• Perform root cause analysis and corrective/preventive action (CAPA) investigations.
• Review, approve and execute/support validation protocols, reports, and production documentation.
• Conduct quality inspections, audits, and statistical process control (SPC).
• Create and maintain Failure Modes, Effects Analysis (FMEAs) for processes
• Participate in and/or support supplier management process, including supplier approval, SCARs, audits, etc.
• Documentation & Reporting:
• Create and revise quality procedures, work instructions, and control plans for new and existing machines
• Maintain accurate records of testing, inspections, and quality metrics.
• Maintain raw material and internal product specifications
• Continuous Improvement:
• Lead or support Lean/Six Sigma and continuous improvement projects.
• Analyze process data to identify trends and areas for improvement.
• Lead or supplier management of change projects.
• Cross-functional Support:
• Collaborate with Engineering, Production, and Regulatory teams to ensure product quality throughout the development and manufacturing lifecycle.
• Interface with customers on quality-related matters, including complaints and audits.
• Ability to support our other Business Unit plants, on an as needed basis

• Ensuring all quality standards and procedures are maintained, including training and monitoring of new and existing employees in the processes and methods required to achieve the company’s standards for quality consistent with company principles.
• Overseeing the maintenance of related test equipment, including, calibrations, repair, servicing ordering supplies, training personnel as needed.
• Other duties as assigned

REQUIRED QUALIFICATIONS

• Bachelor’s degree in Engineering, Quality, or a related technical field.
• 5+  years of experience in a quality engineering role, preferably in medical device, pharmaceutical, or regulated manufacturing environment.
• Working knowledge of ISO 13485, FDA QSR, and GMP.
• 6 Sigma Belt Certification-Preference of at least Green Belt Certification
• Proficiency in root cause analysis tools (e.g., 5 Whys, Fishbone, FMEA).
• Experience with statistical tools and software (e.g., Minitab, Excel).
• ASQ Certified Quality Engineer (CQE) or equivalent is a plus.
• Strong interpersonal and communication skills.
• Prior experience with Intelex
• Ability to work with production operators on the manufacturing floor

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.