Quality Engineer

Role details

Reporting Relationship

Quality Assurance Manager

Classification

Technical individual contributor.

Position Purpose

The Quality Engineer is a technical member of the Quality team who supports the Quality Assurance Manager in building and sustaining a proactive, prevention-based quality system for a growing medical device contract manufacturer. The role applies metrology, statistical analysis, and structured problem solving to ensure the processes used to make and deliver products are capable, controlled, and continuously improved, rather than relying on detection and inspection alone.

Working closely with Engineering, Production, and Supply Chain, this position supports the manufacture of high-volume, high-tolerance medical molded components by analyzing data from IQMS and other sources, maintaining measurement systems and inspection methods, and leading quality improvement and troubleshooting projects. The position provides periodic inspection coverage when needed and helps train Quality staff on measurement and statistical methods.

Essential Functions and Basic Duties

Metrology and Inspection Methods

• Serve as the technical resource for dimensional measurement, including OGP (Optical Gaging Products) vision systems, CMM, optical comparators, and hand gauges.
• Develop, review, and validate inspection programs and methods; interpret customer drawings and specifications, including GD&T.
• Lead Measurement System Analysis (MSA), including Gage R&R studies, to ensure measurement systems are capable and reliable.
• Perform inspection, including first article inspection (FAI), when needed to cover workload increases or staffing shortages, in accordance with documented training and competency requirements.

Statistical Analysis and Data

• Apply statistical tools and techniques (SPC, control charts, process capability Cp/Cpk/Pp/Ppk, hypothesis testing, DOE, and sampling plans) to monitor and improve high-volume, high-tolerance molding processes.
• Extract, analyze, and report quality data from IQMS and other sources such as inspection systems, SPC software, and customer feedback to identify trends, root causes, and improvement opportunities.
• Develop statistically based sampling plans and sample-size rationale for inspection and studies.
• Develop and maintain quality metrics and dashboards (e.g., scrap, yield, PPM, first-pass yield, customer complaints) and present results to the QA Manager and leadership.

Continual Improvement and Problem Solving

• Lead and facilitate cross-functional improvement and troubleshooting projects to resolve recurring quality issues.
• Apply structured problem-solving methods (8D, 5 Why, Fishbone/Ishikawa, Pareto analysis, Lean and Six Sigma tools) to identify and eliminate root causes.
• Assist in developing and maintaining Process FMEAs (PFMEA), Control Plans, and process flow diagrams, and work with Engineering during new product introduction to identify critical-to-quality (CTQ) characteristics and inspection plans.
• Work with Engineering and Production to implement error-proofing (poka-yoke) and process controls that prevent nonconforming product.
• Verify the effectiveness of improvements and ensure changes are standardized in procedures, work instructions, and Control Plans.
• Provide technical analysis, such as root cause investigation and statistical rationale, to CAPA, MRB, and validation activities led by others.

Collaboration and Support

• Support internal and external audits as a technical resource.
• Train Quality Technicians, Inspectors, and production personnel on measurement methods, statistical tools, and good documentation practices.
• Support the QA Manager in scaling quality systems and processes to meet the needs of a growing organization.
• Perform other duties as assigned that are necessary for the success of Pres-Tek Plastics.

Qualifications

Preferred Education/Certification

• Bachelor's degree in Engineering (Quality, Industrial, Mechanical, Plastics, or Manufacturing), a technical field, or a related science; an equivalent combination of education and experience will be considered.
• ASQ certification: Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA).
• Six Sigma Green Belt or Black Belt preferred.

Preferred Experience

• 3+ years of quality engineering experience in a regulated manufacturing environment (medical device or other high-volume, high-tolerance manufacturing); injection molding experience strongly preferred.
• Hands-on experience with dimensional measurement and metrology, including CMM, optical comparators, and hand gauges; OGP vision system experience preferred, and training will be provided.
• Experience applying SPC, process capability studies, and MSA/Gage R&R in a production environment.
• Experience leading root cause analysis and continual improvement projects.
• Experience extracting and analyzing data from IQMS or a comparable ERP/MES system.

Preferred Knowledge

• Statistical tools: SPC, process capability (Cpk/Ppk), MSA/Gage R&R, DOE, hypothesis testing, and statistically based sampling plans (e.g., ANSI/ASQ Z1.4, c=0).
• Quality tools: PFMEA, Control Plans, APQP/PPAP concepts, and structured root cause analysis (8D, 5 Why, Fishbone).
• Standards and quality processes: ISO 13485, ISO 9001, FDA 21 CFR Part 820 (QMSR), ISO 14971 risk management principles, and working knowledge of CAPA, MRB, change control, and IQ/OQ/PQ validation.
• Injection molding processes and scientific molding principles, and how process parameters affect part quality.
• Blueprint reading and GD&T.
• Statistical software (Minitab or similar) and advanced Microsoft Excel; strong proficiency in Microsoft Office.

Preferred Skills / Abilities

• Proactive, prevention-focused mindset with the ability to anticipate risks and act before issues occur.
• Strong analytical and data-driven decision-making skills.
• Ability to lead cross-functional teams and drive change without direct authority.
• Strong project management skills, with the ability to manage multiple priorities in a fast-paced, growing environment.
• Accurate and detail-oriented, with a strong commitment to good documentation practices.
• Ability to coach, train, and mentor others.
• Good judgment and sound technical decision making.
• Ability to work independently and as a member of a cross-functional team.
• Represents the company in a professional manner with customers, suppliers, and auditors.
• Ability to communicate effectively (written and spoken) at all levels of the organization, including technical reports and audit responses.
• Regular attendance required.

Physical Requirements

• Involves sitting, standing and/or walking, with frequent ability to exert up to 10 pounds of force to move objects and occasionally exert up to 30 pounds of force to move objects.
• Ability to extend hands or arms in any direction. Repetitive motions, physical ability to sustain movements of the fingers, wrists, hands or arms.
• Hearing, ability to receive detailed information through oral communication and to make discriminations in sound.
• Ability to express or exchange information by means of spoken word.
• Must be able to see (depth perception, near acuity and far acuity) and see colors.
• Must be able to maneuver safely around moving equipment and/or in congested manufacturing areas.
• Must be able to wear personal protective equipment including safety glasses, ear plugs, steel toed shoes, rubber gloves/boots, etc.
• Exposed to various packaging materials, raw ingredients, cleaning chemicals, lubricants, etc.

Pay: $40.00 - $50.00 per hour

Expected hours: 8.0 per week

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Parental leave

Work Location: In person