Job Description

SUMMARY

The Quality Engineer is responsible for bringing new products and processes to market on time and within budget, with strong focus on process qualification, product quality, packaging validation, and continuous improvement. This role works cross-functionally with engineering, operations, and external partners to ensure compliance with regulatory, customer, and internal requirements, while fostering a culture of quality and accountability.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Lead and support process qualifications and validations, including packaging validation (protocol development, execution, data analysis, and reporting) per ISO 11607, ISO 13485, and customer requirements.

• Act as lead quality reference for internal and external customers regarding additive manufacturing, coatings, packaging, and assembly applications.

• Read, analyze, and interpret customer and regulatory specifications; manage qualification kickoff meetings and drive actions to closure.

• Develop, revise, and maintain quality procedures, inspection plans, control plans, FMEAs, and work instructions.

• Establish and maintain effective document control practices in support of product assurance and regulatory compliance.

• Implement inspection and test methods, including sampling plans and acceptance criteria, ensuring alignment with industry standards

• Lead root cause analysis and corrective/preventive actions (8D, 5 Whys) to permanently eliminate nonconformities.

• Support internal and supplier audits to verify compliance with Quality Management System (ISO 13485, FDA 21 CFR Part 820) and customer requirements.

• Monitor and analyze key metrics (Quality, Rework, Scrap Cost) and implement continuous improvement initiatives using Lean and Six Sigma tools.

• Provide training to production and quality personnel on quality procedures, inspection techniques, and regulatory awareness.

• Support vendor qualification and material approval activities by coordinating with suppliers to resolve quality issues and ensure compliance with specifications.

• Participate in customer and notified-body audits.

• Other duties as assigned.

SUPERVISORY RESPONSIBILITIES

None QUALIFICATIONS

Bachelor's degree in Engineering, Material Science, or related technical field.

Minimum 3–5 years of experience in a regulated manufacturing environment (medical device, aerospace, or equivalent).

Proven experience in process validation (IQ/OQ/PQ) and use of risk management tools (FMEA, Control Plan).

Understanding of ISO 13485 and 21 CFR 820 Quality System Regulations.

Ability and willingness to take ownership of packaging validation and sterile barrier qualification activities, learning and applying ISO 11607 principles through hands-on project execution and cross-functional collaboration.

Hands-on experience with inspection methods, sampling plans, and acceptance criteria development.

Strong analytical and problem-solving skills using root cause analysis tools (8D, 5-Why, Fishbone).

Excellent written and verbal communication skills, including the ability to interface effectively with customers, auditors, and cross-functional teams.

Proficiency in Microsoft Office and familiarity with ERP systems (SAP, Oracle, or equivalent).

Preferred: Master's degree in Engineering, Quality, or related discipline.

Preferred: Exposure to medical device packaging, clean-room assembly, or sterilization validation processes.

Preferred: Certification or practical experience in Lean Six Sigma (Green Belt or higher).

Preferred: Working knowledge of Minitab or other statistical analysis tools (SPC, capability studies, GR&R).

Preferred: Experience with supplier audits, NPI/APQP, or customer qualification activities.

Preferred: Ability to read and interpret engineering drawings, GD&T, and use precision measurement tools.

EDUCATION and/or EXPERIENCE

Bachelor's degree in Engineering, Material Science, or related field required; Master's preferred.; or more than three years' related experience and/or training; or equivalent combination of education and experience.

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 write speeches and articles for publication that conform to prescribed style and format. 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 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 close vision, color vision, depth perception, and ability to adjust focus.

Lincotek Medical 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 .

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