Quality Control & Calibration Supervisor

Company Description

Lincotek, headquartered in Rubbiano, Parma, Italy, is a global contract manufacturer for services in markets including Industrial Gas Turbines, Aerospace and Medical Device applications, as well as a leading manufacturer of industrial coating equipment and one of the most respected producers in the Additive Manufacturing field. The Group has more than 1,800 employees located in 18 production facilities across Europe, North America and Asia.

Position

SUMMARY:. The Quality Control Supervisor is responsible for leading the daily activities of the Quality Control department, including supervision of Quality Inspectors, Calibration personnel, and external inspection resources as assigned. This role ensures timely product inspection and release while maintaining compliance with applicable regulatory requirements, customer specifications, and internal quality standards. The supervisor provides technical leadership in inspection methods, metrology, calibration, and continuous improvement, while coaching and developing personnel to support operational excellence and customer satisfaction. Ensures regulatory requirements are met for the medical industry including FDA/ISO regulations.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Supervise the daily activities of the Quality Control department, including Quality Inspectors, Calibration personnel, and external inspection resources as assigned.
• Ensure inspection activities support production priorities and assigned times while maintaining compliance with quality standards and customer requirements.
• Review and approve Device History Records (DHRs), Certificates of Compliance (CoCs), and other quality documentation required for product release.
• Ensure inspection methods, metrology practices, and calibration activities are performed in accordance with company procedures and applicable standards.
• Provide technical guidance on inspection techniques, engineering drawings, and Geometric Dimensioning & Tolerancing (GD&T).
• Support investigations of nonconforming products and implementation of corrective actions as appropriate.
• As needed, support external audit functions. Includes participating with vendor, ISO and/or FDA audits.
• Ensure compliance with FDA Quality System Regulations, ISO 13485, and company quality system requirements.
• Experience with statistical principles, data collection and reduction utilizing appropriate software tools.
• Perform other duties as assigned.

SUPERVISORY RESPONSIBILITIES

• Directly supervise Quality Control personnel, including Quality Inspectors, Calibration personnel, and external inspection resources as assigned.
• Effectively evaluates QC department's performance and provides coaching and mentoring to set performance standards, assess performance capability, and prescribe remediation (including coaching, learning assignments, and training opportunities).
• Conduct hiring, disciplining and terminating according to the implemented policies in a fair and defensible professional manner.
• Motivates their team to define and meet performance expectations and, while collaborating effectively across functional boundaries.
• Coordinate daily work assignments and resources to meet production priorities while maintaining compliance with quality and regulatory requirements.
• Other duties as assigned.

Requirements

EDUCATION and/or EXPERIENCE

High School Diploma or G.E.D. required. Prefer a bachelor's degree (B. A./ B. S.) from four-year college or university; over 2 years' relevant experience and/or training; or equivalent combination of education and experience.

KNOWLEDGE, SKILLS, AND ABILITIES

Knowledge of FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and Good Documentation Practices.

Ability to interpret engineering drawings and Geometric Dimensioning & Tolerancing (GD&T).

Knowledge of metrology principles, calibration systems, and precision measurement equipment.

Experience with statistical techniques, including SPC, MSA, and Gauge R&R.

Proficiency with Microsoft Office and quality-related software systems.

LANGUAGE SKILLS

Excellent communication skills. Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management, public groups, and/or boards of directors.

MATHEMATICAL SKILLS

Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical and statistical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

REASONING ABILITY

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 and deal with several abstract and concrete variables.

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 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 talk or hear. The employee is occasionally required to stand; walk; sit; use hands to handle or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds.Specific vision abilities required by this job include color differentiation and pass annual visual exams.

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