Quality Control Inspector II

PRIMARY FUNCTIONS

The QC Inspector II is responsible for performing complex dimensional and visual inspections on high-precision orthopedic implants and instruments. This role focuses on the execution of established CMM programs and the use of advanced manual metrology tools to ensure 100% compliance with FDA, ISO 13485, and customer specifications. The ideal candidate functions as a technical resource on the shop floor, bridging the gap between production and quality engineering.

Supports and creates effective teams, units and environments through a personal commitment to the company's vision and values.

May teach selected Quality Control Inspector I level employee's principles and techniques.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each of the Major Responsibilities, including the following:

• CMM Operation: Execute established CMM programs (PC-DMIS) for in-process and final inspections. Perform probe calibrations and troubleshoot basic software execution errors.
• Precision Measurement: Perform First Article Inspections (FAI), in-process, and final inspections using calipers, micrometers, height gauges, optical comparators, and surface finish testers.
• Blueprint & GD&T Expertise: Interpret complex engineering drawings with a high level of proficiency in GD&T (Geometric Dimensioning and Tolerancing) per ASME Y14.5.
• Documentation & Compliance: Maintain meticulous records in accordance with Good Documentation Practices (GDP). Review Device History Reports (DHR) to ensure full traceability of orthopedic components.
• Non-Conformance Management: Identify, tag, and segregate non-conforming material. Initiate Non-Conformance Reports (NCRs) and assist in root-cause analysis.
• Shop Floor Support: Act as a secondary check for Level 1 Inspectors and provide feedback to CNC Machinists to ensure parts remain within process control limits.

• Requires the ability to learn and meet established department specific work instructions and procedures.
• Inspects various parts; completed and/or in process products, recording and maintaining quality records, to ensure compliance with all quality requirements.
• Work demands a high degree of accuracy and close tolerance inspection.
• May be required to understand and demonstrate proficiency in geometric tolerances and must have basic Math skills.
• Willingly accepts responsibility of sharing skills and knowledge; trains other employees as needed.
• Responsibilities include understanding and knowledge of production/manufacturing inspection processes and procedures.
• Understands and meets quality standards. Seeks to minimize reject rate.
• Participates in continuous improvement efforts. Supports and helps to implement new ideas.
• Possesses the ability to use the computer system for basic departmental functions.
• Ability to understand print specifications including, product specifications, equipment dimensions, etc.

• Familiarity or understanding of lathe and mill machining processes as required.
• Proficient with precision inspection instruments (e.g. micrometers, calipers, laser mic, optical comparator, toolmakers scope, Smart Scope, CMM, etc.)
• Effectively handles multiple tasks.

• Works overtime as necessary.

• Other duties as assigned.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE:

• Experience: 3–5+ years of mechanical inspection experience in a regulated industry (Medical Device preferred; Aerospace or Semiconductor accepted).
• Technical Skills: Proven experience operating CMMs and a solid grasp of manual layout inspection techniques.
• Knowledge: Working knowledge of ISO 13485 or FDA 21 CFR Part 820 standards.
• Education: High School Diploma required; ASQ Certified Quality Inspector (CQI) or technical trade certification is a strong plus.

LANGUAGE SKILLS:

• Ability to read, write, and comprehend simple instructions
• Ability to effectively present information in one-on-one and small group situations to other employees of the organization.
• Effectively gives and receives feedback; willingly asks questions and seeks direction as needed.

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 and to draw and interpret bar graphs.

REASONING ABILITY:

• Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form.
• Ability to deal with problems involving several concrete variables in standardized situations

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 accommodation may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to handle or feel; reach with hands and arms; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, and color vision, depth perception, peripheral vision and ability to adjust focus.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.

Lincotek provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.