Integer Holdings Corporation→
Quality Inspector II at Integer… · Brooklyn…
Entry LevelOn-siteFull-timeBrooklyn Park, MN$45k–$67k/yr
Skills
manufacturing practices (gmp)quality system guidelinesnon-conformance report (ncr) processmeasurement tools and equipmentpin gagecaliperoptical comparatorsmartscopepull testercalibrationsampling plansoracle quality modulesfirst article inspectioncorrective and preventive actions (capa)gd&tiso9001iso13485ipc certificationmicrosoft officeengineering drawings interpretationtolerance knowledgebasic mathematics
Job Description
Summary: Integer Holdings Corporation is a global organization providing innovative technologies and manufacturing solutions for Medical Device OEMs. The Quality Inspector II role is responsible for supporting and performing the inspection and testing processes of materials and products, ensuring compliance with quality standards and Good Manufacturing Practices (GMP).
Responsibilities:
- Perform visual, dimensional and/or functional inspections for each raw material, in-process assembly, or finished product in accordance with authorized specification and applicable quality standards
- Identify and segregate non-conforming materials and initiate the NCR process
- Utilizes measurement tools/equipment and hand gages to measure physical dimensions and other attributes (e.g. pin gage, caliper, optical comparator, SmartScope, pull tester, etc.). Ensures current calibration
- Recommends appropriate gages and other equipment for the measurement of products or parts
- Compiles or completes quality records, reports, and/or documentation for product, material and equipment inspection ensuring GDP (Good Documentation Practices) are applied
- Understands and adheres to sampling plans
- Performs support in material transactions in Oracle
- Participates in the first article inspection processes
- Supports process audits and provides feedback to manufacturing cell regarding Quality findings
- Update COC, COA and etc via customer portal/system (SQM, eCert)
- Participates in problem solving and provides input for process/product evaluations for continuous improvement
- Performs other duties as assigned
- Expands skill base through on-the-job training, cross training and classroom instruction
- Trains personnel in proper inspection techniques, systems, equipment, and processes
- Provides support/guidance, data and analysis to other departments
- Continually seeks to drive improvements in product and process quality and identifies and escalates quality non-conformances to assist in achieving company quality objectives and key business metrics
- Adheres to Integer Core Beliefs, Safety and Quality requirements and applicable regulations described in the quality management system (QMS)
- You embed Quality within your daily work life – “I own Quality.” You are a standard bearer for Quality in everything we do at Integer, by assuring adherence to our Quality Management System (QMS), facilitating and/or contributing to corrective and preventive actions, and contributing to the successful attainment of our quality KPI’s and journey to 5 Sigma
- Live the Integer Values through leading by example
- Assist the site in achieving its annual goals for safety, quality, delivery, cost, and inventory
- Achieve all Goals and Objectives assigned
Required Qualifications:
- High school graduate or equivalent may be required
- 1 year of work experience as a Quality Inspector or 2 years of related inspection experience in the manufacturing industry may be required
- Understanding of GD&T
- Understanding of the ISO9001/ISO13485 quality standards preferred
- Product knowledge helpful
- Computer operation skills (Microsoft Office, Oracle Quality modules)
- Ability to read and interpret sampling and inspection plans and engineering drawings
- Experience with the use of measurement tools/equipment and hand gages to measure physical dimensions and other attributes (e.g. pin gage, caliper, optical comparator, SmartScope, pull tester, etc.)
- Experience measuring physical dimensions on parts
- Good organizational and communication skills
- Detail oriented and organized
- Knowledge of tolerances
- Basic Mathematics knowledge
Preferred Qualifications:
- Associate's degree or experience in inspection preferred
- Some Associate's degrees may substitute for years of experience
- IPC certification preferred
Required Skills: Manufacturing Practices (GMP), Quality System Guidelines, Non-Conformance Report (NCR) Process, Measurement Tools and Equipment, Pin Gage, Caliper, Optical Comparator, SmartScope, Pull Tester, Calibration, Sampling Plans, Oracle Quality Modules, First Article Inspection, Corrective and Preventive Actions (CAPA), GD&T, ISO9001, ISO13485, IPC Certification, Microsoft Office, Engineering Drawings Interpretation, Tolerance Knowledge, Basic Mathematics
Benefits: 22% shift differential, Base wages, A cash-based incentive program supporting our pay-for-performance philosophy, Overtime pay, Shift differentials, Call-in pay, when applicable, A comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits, Parental leave is available after one year, Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance, Employees are immediately eligible to participate in the 401(k) plan with company matching contributions, 80 hours (10 days) of company designated holidays per year, An annual allotment of paid time off
Benefits
22% shift differential
Base wages
A cash-based incentive program supporting our pay-for-performance philosophy
Overtime pay
Shift differentials
Call-in pay, when applicable
A comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits
Parental leave is available after one year
Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance
Employees are immediately eligible to participate in the 401(k) plan with company matching contributions
80 hours (10 days) of company designated holidays per year
An annual allotment of paid time off