Functional Job Family Description
A Quality & Reliability Technician uses their technical skills to assist in issues related to the Quality of the product. This job also involves leveraging technical skills to resolve issues related to the product to meet quality goals.
Nature and Overall Purpose of the Role Performed
Apply problem-solving techniques
Working align requirements in the medical industry (FDA regulations), ISO 13485.
Apply spreadsheets, databases, and Process Control Monitoring (SPC).
• Participate in process improvement.•
KEY RESPONSIBILITIES& TASKS
Responsibility Includes the Following Tasks
Conduct inspection activities, when support is necessary, to ensure the quality of products and raw materials used in the manufacture of products meeting customer expectations and internal standards.
Responsible for ensuring the disposition of non-conforming product and material as appropriate.
Manage the work schedule for inspectors.
Monitor break times to ensure that employees are following established break times.
Discipline inspectors when not performing duties as required.
Monitor production operators for adherence to quality requirements. Interact with leaders and supervisors to ensure operators are following requirements.
Interact with Production Control to facilitate activities.
Conduct training for staff to ensure compliance with company procedures.
Ensure a high level of internal and external customer service.
Follow all other duties as assigned by the Quality Engineer.
Create and follow up on NCMR's.
Create change plan according to the quality system.
Ensure procedures are up to date.
Must be able to support departments such as Doc Control, Training, Calibrations, Incoming, Environmental Monitoring, Pest Control and Methods.
What your background should look like:
COMPETENCIES & SKILLS
Core Competencies
Technical Learning - Picks up on technical things quickly; can learn new skills and knowledge; is good at learning new industry, company, product, or technical knowledge; does well in technical courses and seminars.
Problem Solving- Uses rigorous logic and methods to solve difficult problems with effective solutions; probes all fruitful sources for answers; can see hidden problems; is excellent at honest analysis; looks beyond the obvious and doesn’t stop at the first answers.
Ethics and Values - Adheres to an appropriate (for the setting) and effective set of core values and beliefs during both good and bad times; acts in line with those values; rewards the right values and disapproves of others; practices what he/she preaches.
Action Oriented - Enjoys working hard; is action oriented and full of energy for the things that he/she sees as challenging; not fearful of acting with a minimum of planning; seizes more opportunities than others.
Job Specific Knowledge, Skills and Abilities
Knowledge - NCMRs/CARs.
Skills- Working under pressure.
Abilities- Comprehension and understanding of information and ideas.
Language: Bilingual English (Basic)/ Spanish.
Ability to communicate effectively in oral and written form.
Ability to read and interpret documents such as job travelers, blueprints, sketches, diagrams and other process materials or documents.
Fundamental knowledge of geometry, fractions, percentages, ratios, statistics and measurements.
Ability to gather relevant data, establish the facts and find a solution.
Organizational / effective time management skills applied in a fast moving pressure filled environment.
Ability to work independently with little or no supervision as well as in a team environment.
Effective interpersonal skills and proficiency in working with culturally diverse population.
Knowledge of measurement instruments, sampling plans, NCs, CAPAs, and document changes.
EXPERIENCE & EDUCATIONAL REQUIREMENTS
Experience
1 year of experience in plastic transformation processes
0-1 year of experience in a Quality Inspector V position. Quality leadership experience working in a manufacturing environment.
Education
High School Diploma.
Technical course in quality or related (or with 50 % of the technical degree completed).