QA/QC Specialist - Manufacturing & Assembly

Job Summary

The QA/QC Specialist ensures products services and processes meet quality and regulatory standards through effective Quality Assurance (QA) and Quality Control (QC) practices. This role involves developing and implementing quality systems conducting inspections and audits and collaborating with cross-functional teams to resolve quality issues and drive continuous improvement. The specialist plays a key role in maintaining compliance improving product reliability and enhancing customer satisfaction.

Responsibilities

Essential Functions

• Develops and maintains QA/QC policies procedures and documentation in compliance with industry standards (e.g. ISO 9001 GMP).
• Conducts risk assessments and implements quality plans to prevent potential issues.
• Reviews and updates SOPs to meet regulatory and organizational requirements.
• Performs internal audits and inspections to ensure compliance with quality standards.
• Inspects and tests raw materials in-process and finished products against specifications.
• Investigates non-conformances and implements corrective/preventive actions (CAPA).
• Uses testing tools and software to evaluate product quality and maintain detailed records.
• Monitors quality metrics and leads continuous improvement initiatives (e.g. Six Sigma Lean).
• Ensures compliance with regulatory requirements (e.g. FDA OSHA EPA) and supports external audits.
• Calibrates and maintains records for testing equipment.
• Trains staff on QA/QC procedures and promotes a culture of quality.
• Collaborates with cross-functional teams and suppliers to resolve quality issues and meet customer-specific requirements.

Non-essential Functions

• Supports internal communication efforts related to quality programs or achievements.
• Aids in preparing quality-related content for training materials or onboarding programs.
• Attends industry seminars workshops or conferences to stay updated on best practices and trends.
• Performs other duties as assigned by supervisor or other designate.

Qualifications

• Bachelors degree in engineering quality management science or a related field or equivalent years of experience required
• 2 years of experience in quality assurance/quality control in manufacturing/assembly or supply chain.
• Experience with quality management systems ISO 9001
• Familiarity with regulatory standards relevant to the industry (e.g. FDA GMP OSHA).

Skills and Abilities

• Strong knowledge of QA/QC principles methodologies and tools (e.g. statistical process control root cause analysis).
• Proficiency with quality inspection tools and equipment (e.g. calipers etc.)
• Proficiency in Microsoft Office Suite and quality management software (e.g. SAP Minitab or similar).
• Excellent analytical and problem-solving skills with a keen attention to detail.
• Ability to interpret technical drawings specifications and standards.
• Strong written and verbal communication skills for reporting and collaboration.
• Ability to work independently and as part of a team in a fast-paced environment.
  

Physical Requirements

Frequency at which you would carry/lift in a typical day:
Occasionally 0 33% Frequently34 66% Continuously: 67 100%

• Lift from Waist:
  • < than 10 lbs. - Not at all
  • 10 to 25 lbs. - Not at all
  • 26 to 50 lbs. - Not at all
  • 51 to 75 lbs. - Not at all
  • 75 to 100 lbs. - Not at all
  • 100 lbs. - Not at all
• Lift from Floor:
  • < than 10 lbs. - Occasionally
  • 10 to 25 lbs. - Occasionally
  • 26 to 50 lbs. - Occasionally
  • 51 to 75 lbs. - Occasionally
  • 75 to 100 lbs. - Not at all
  • 100 lbs. - Not at all
• Carried for Distance:
  • < than 10 lbs. - Not at all
  • 10 to 25 lbs. - Not at all
  • 26 to 50 lbs. - Not at all
  • 51 to 75 lbs. - Not at all
  • 75 to 100 lbs. - Not at all
  • 100 lbs. - Not at all

Physical Activity

Frequency at which you would do the following in a typical day:

• Sitting (a continuous period of being seated) - Frequently
• Standing (for sustained periods of time) - Frequently
• Walking (moving about on foot to accomplish tasks) - Frequently
• Bending/stooping (downward and forward) - Occasionally
• Crawling (moving about on hands and knees or hands and feet) - Not at all
• Climbing/Walking Stairs (ascending or descending) - Occasionally
• Reaching (extending arms in any direction) - OFrequently
• Crouching/squatting (bending the body downward and forward by bending leg and spine) - Occasionally
• Kneeling (bending legs at knee to come to rest on knee(s)) - Occasionally
• Balancing (maintaining body equilibrium to prevent falling) - Occasionally
• Repetitive motion (substantial movement (motions) or the wrists hands and/or fingers) - Continuously
• Pivoting (movement in any direction with one foot keeping the other in contact with the floor) - Occasionally
• Pushing/Pulling (using upper extremities to press against or draw or tug) - Occasionally
• Grasping (Applying pressure to an object with the fingers and palm) - Continuously
• Fingering (picking pinching typing; working with primarily fingers and not whole hand) - Frequently
• Talking (expressing or exchanging ideas by means of the spoken word) - Frequently
• Driving (the control and operation of a motor vehicle) - Occasionally
• Desk work (work usually performed at a desk) - Frequently
• Use of a computer - Frequently
• Use of a telephone - Frequently
• Hearing (Perceiving the nature of sounds at normal speaking levels) - Continuously
• Exposure (to adverse weather & temperature conditions) - Occasionally
• Travel (travel needed to perform job duties) - Occasionally

Additional Information

This job description is a summary of the job duties and responsibilities and is not intended to cover all possible job duties and is subject to change at the employers discretion. Employees must be able to perform the essential job duties and satisfy job requirements either with or without a reasonable accommodation.