Customer Quality Engineer

Pharmatech, Inc.; Lindon (UT); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

401(k) with company match

Paid Time Off

Paid Holidays

Professional development

Job summary

Pharmatech Labs is seeking a Quality Engineer to maintain and improve the QMS in a fast-paced manufacturing environment. You will lead investigations, coordinate with customers, and drive CAPA activities to preserve product quality and regulatory compliance.

The role requires a technical bachelor's degree and 2–5 years in quality or manufacturing quality, with experience in audits, NCRs, and QMS documentation. Collaboration with multiple departments is essential.

Qualifications

• Bachelor’s degree in a technical field and 2–5 years in quality/regulated environments.
• Experience with customer complaints, NCRs, CAPA, audits, and QMS documentation.
• Knowledge of cGMP, FDA, SQF, HACCP or similar standards preferred.

Responsibilities

• Act as liaison between Pharmatech Labs and clients on quality issues and resolutions.
• Lead root cause analyses in response to customer complaints and non-conformities.
• Ensure communications with customers are thorough, clear, and concise.
• Identify opportunities to improve quality processes and systems.
• Support internal audits to ensure regulatory compliance and SOP adherence.
• Participate in external audits (regulatory, certification, customer).
• Collaborate with Manufacturing to ensure quality standards are understood and applied.
• Provide training to manufacturing staff on quality standards and best practices.
• Participate in MRB meetings and present findings.
• Track QMS health and present trends at Management Review meetings.

Skills

Quality Management Systems

Root cause analysis

Customer communication

Analytical thinking

Documentation accuracy

Cross-functional collaboration

Audits

Education

Bachelor’s degree in technical discipline

Job description

At Pharmatech, we make life better! We are committed to building a positive and supportive culture of transparency and honesty, striving for the well-being of our teams, customers, and community. We offer competitive compensation, benefits, and opportunities for continuous growth. Our core values are people, customer service, team, and continuous improvement. If this aligns with your personal core values, please apply to join our team!

Industry:

Employment Type:

Job Summary:

Quality Engineer (QE) performs a key function in maintaining and improving the Quality Management System (QMS) at Pharmatech. QE is a leadership and customer-facing role requiring clear understanding and execution of quality and regulatory requirements. When performed well, the QE naturally bolsters the company reputation and customer relationships, providing an unrivaled experience through communication, transparency, collaboration, and improvement.

Employment Type:

Key Responsibilities Include, but are not limited to:

• Act as a liaison between Pharmatech and the client addressing quality issues and resolutions.
• Lead root cause analysis efforts in response to customer complaints and/or non-conformities (NCRs).
• Ensure that communications with customers are thorough, yet clear and concise.
• Play an active role in identifying opportunities to improve quality processes and systems.
• Support internal audits to ensure compliance with regulatory requirements, company policies, and standard operating procedures.
• Participate in external (regulatory, certification, and customer) audits.
• Work closely with the manufacturing team to ensure quality standards are understood and consistently applied.
• Provide training and support to manufacturing staff on quality standards and best practices.
• Participate and present in regular Material Review Board (MRB) meetings.
• Track and trend the health of the QMS, and present in annual Management Review meeting.

Education & Experience:

• Bachelor’s degree in technical discipline.
• 2–5 years of experience in quality assurance, quality engineering, manufacturing quality, compliance, or a related quality role preferred.
• Experience in regulated manufacturing environment preferred.
• Experience with customer complaints, non-conformance reports, corrective actions, root cause analysis, audits, and QMS documentation preferred.
• Knowledge of cGMP, FDA, SQF, HACCP, or other applicable quality and regulatory standards preferred.

Required Skills & Abilities:

• Strong understanding of Quality Management Systems, quality assurance principles, and regulatory compliance requirements.
• Ability to lead investigations, root cause analysis, and corrective/preventive action activities.
• Excellent written and verbal communication skills, especially when communicating with customers and internal leadership.
• Strong analytical, problem-solving, and critical-thinking skills.
• Ability to interpret quality data, identify trends, and recommend practical improvements.
• Strong attention to detail with the ability to maintain accurate documentation and records.
• Ability to work cross-functionally with Manufacturing, Quality, Operations, R&D, Customer Service, and leadership teams.
• Comfortable participating in audits, inspections, MRB meetings, and management review discussions.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.
• Professional, collaborative, and customer-focused approach.

Working Conditions:

• Work is performed in both office and manufacturing environments.
• Regular interaction with customers, internal departments, production teams, and quality personnel.
• May be exposed to manufacturing conditions, including noise, moving equipment, machinery, raw materials, and temperature variations.
• May require use of personal protective equipment such as safety glasses, hearing protection, gloves, hairnets, beard nets, lab coats, or other required PPE.
• Requires frequent use of a computer, phone, email, quality systems, spreadsheets, documentation, and reporting tools.
• May require standing, walking, bending, and moving throughout the facility to support audits, investigations, training, inspections, and quality activities. Must be able to manage multiple priorities, deadlines, customer expectations, and quality issues in a fast-paced environment.

Benefits:

• Comprehensive health, dental, and vision insurance.
• 401(k) plan with company match.
• Paid Time Off.
• Paid Holidays.
• Professional development and training opportunities.

Pharmatech Labs is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.