Job Description
Job Overview:
Job Summary
The Senior Quality Inspector is responsible for ensuring that company medical device products meet all applicable quality, regulatory, and customer requirements throughout the manufacturing process. This role will focus on using their knowledge and experience to perform and improve calibration, inspection, sampling, gage R & R, and other QC functions. As a Senior Quality Inspector, this position will also provide technical guidance, training, and mentorship to Quality Inspectors and production personnel.
Other duties may be assigned as needed to ensure that all Company products are materially free of defects, that quality system procedures are followed, and that products are manufactured in a way that complies with the Company quality system and industry regulations.
Essential Functions
Job Responsibilities
- Perform mechanical inspections with hand tools and CMM using established procedures and specifications.
- Manage and improve calibration program along with calibration of mechanical inspection hand tools such as: calipers, pin gauges, and height gauges.
- Train, mentor, and provide technical guidance to Quality Inspectors and production personnel.
- Assist in establishing effective inspection sampling plans.
- Investigate and resolve product quality problems.
- Recognize improvement opportunities and initiate appropriate actions to streamline processes.
- Assist in establishing and maintaining QC metrics.
- Participate in 5S.
- Interface effectively with other job functions and suppliers.
- Promote a positive influence to foster excellence and positive critical behaviors.
- Read and interpret engineering drawings, technical specifications, and standard operating procedures (SOP’s).
- Analyze inspection data.
- Accurately record inspection results and maintain quality reports and documents in multiple computer applications.
- Identify, document, and coordinate nonconformance control activities including identification, recording, disposition, supplier communication, sorting, rework, and resolution.
- Support root cause investigations and corrective and preventative actions (CAPA) as needed.
- Support and perform assigned project-based work.
- Participate in internal/external audits and continuous improvement projects as needed.
- Ensure adherence to ISO 13485, FDA 21 CFR Part 820, and other applicable regulations.
- Maintain a safe, neat and orderly work environment.
- Ensure and follow safety requirements and standards.
- Adhere to Company’s Quality System requirements.
- Performs all duties in a manner that follows, demonstrates, and promotes Company’s values.
- Report to work as scheduled, on time, and able to work entire work schedule.
- Perform additional duties as assigned.
Knowledge, Skills, and Ability
- Skill and ability in CMM operation.
- Math proficiency sufficient to perform tasks such as inspection calculations, basic statistical analysis, and creating credit memos.
- Skill and ability to read and interpret mechanical drawing including GD&T.
- Ability to calibrate inspection tools such as calipers, pin gauges, and height gauges.
- Working knowledge of problem-solving tools such as is/is not, fishbone, pareto, Five Why, and correlation.
- Detailed oriented with the ability to analyze data and draw conclusions.
- Possess effective written and oral communication skills.
- Basic proficiency using computer applications (Word, Excel, enterprise software).
- Ability to make sound quality decisions using established procedures and technical judgment.
- Able to work effectively both independently and within a team environment.
- Ability to be highly adaptable and responsive to changing business needs.
- Possess a continuous improvement mindset.
- Ability to observe and identify details.
- Ability to work extended hours as scheduled, including weekends.
Physical Demands
- Frequent sitting, wrist manipulation, walking, and standing.
- Frequent light work with lifting up to 10 pounds.
- Occasional medium work with lifting up to 50 pounds.
- Manual dexterity to type and operate office equipment occasionally.
- Must be able to complete all physical requirements to perform essential functions.
Qualifications
Education
- High School Diploma or GED required; Associate degree in Engineering, Manufacturing, Quality, or related technical field preferred.
- Quality Certifications such as ASQ-CQIA, CQI, CQT, Calibration, or Green Belt required.
Experience
- Required:
- Minimum 5 years working in a manufacturing environment.
- Minimum 5 years mechanical inspection experience including CMM.
- Experience reading and interpreting engineering drawings.
- Basic level experience with Microsoft Office programs (Word, Excel) and other enterprise software.
- Preferred:
- Experience working in a Quality Management System controlled environment (ISO 13485, ISO 9001, TS 16949) and/or an FDA regulated environment, preferably in medical device.
- Experience with basic statistics.
- Experience with Lean tools such as 5S, standard work, waste, error proofing, or process mapping.
Working Environment
- Standard working conditions include a temperature-controlled office and manufacturing environment.
This position does not now or in the future provide immigration sponsorship.
This position is subject to a background check. A prior conviction or pending charge will not automatically disqualify you from consideration. In accordance with the Fair Credit Reporting Act and Wisconsin Fair Employment Act, criminal histories will only be evaluated if the circumstances of the offense substantially relate to the duties of this position.
This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the associate for this position. Duties, activities, and responsibilities may change, or new ones may be assigned at any time with or without notice. Associate must be able to satisfactorily perform the essential functions of the position with or without reasonable accommodation.
Ki Mobility is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.
