We are looking for motivated individuals to join our team and help us make an impact in medical device manufacturing!
Primary Responsibilities
- Performs visual and dimensional first piece of primary and secondary operations, in-process, final and first article inspection when needed.
- Proper and accurate utilization of measuring equipment: micrometers, calipers, optical comparator, height gage, indicators.
- Processes non-conforming material, reports data.
- Interprets engineering drawings/blueprints and confers with management or engineering departments to determine quality and reliability standards.
- Accurately enters data into EPICOR ERP.
- Ensures the required documentation is present and accurately fill out.
- Reviews job travelers and in process paperwork to ensure compliance and all criteria are met.
- May be responsible for calibrating, setting up, operating, and troubleshooting Coordinate Measuring Machine (CMM) machines. Should know how to do manual alignments.
- Assists team members with resolutions of any questions/issues that may arise before directing them to Quality MGMT.
- Must work responsibly with or without supervision using effective communication skills; able to collaborate with various departments and all levels of team members.
- Helps reduce scrap/waste, cost, time; drives for continuous improvement.
- Reliable, timely, ethical and consistent attendance.
- Other duties as assigned.
Qualifications
- High School Diploma or equivalent,
- or two to three years of experience, preferably in medical device manufacturing industry.
- or equivalent combination of education, training and/or experience.
- Knowledge of ISO 13485 Quality Management System & FDA 21CFR 820 Regulations is strongly preferred.
- Knowledge of Geometric Dimensioning and Tolerancing per ASME Y14.5M.
- Knowledge of reading and interpreting blueprints and schematics.
- Knowledge of CMM and computer aided inspection systems preferred (PC-DMIS, Keyence).
Language Ability
Ability to read, analyze, and interpret common scientific and technical manuals, training materials, financial reports, and legal documents (specifically in English). Ability to communicate effectively with tact, respect and professionalism within all levels of the organization.
Computer Skills
To perform this job successfully, an individual should have professional and working knowledge of Microsoft office and its applications (Excel), e-mail, communication platforms (Zoom, Teams). Knowledge of manufacturing software and ERP systems (EPICOR is strongly preferred). Knowledge of QCBD preferred.
Certificates and Licenses
No certifications required.
Managing Responsibilities
No direct reports.
Work Environment
Office/Production Environment. This position has exposure to high-speed machinery and equipment and requires the use of safety glasses. The work environment of this position is generally performed in an indoor environment (at times in confined spaces) in a well-lit and ventilated area. There is exposure to machine oil, metal filings, and noise. Job functions on and around mechanized equipment will present the need for alertness, accuracy, and safety awareness.
Physical Demands
The physical demands described must be met by an employee to successfully perform the essential functions of this job: The employee is required to regularly sit for long periods of time and occasionally to stand, walk, sit; use hands to finger, handle, or feel, talk and/or hear; reach with hands and arms. Ability to regularly lift and /or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to adjust focus.
Equal Employer Opportunity
ARCH is an Equal Opportunity Employer who wholeheartedly supports diversity in the workplace as basic premise for business success. We do not discriminate on a basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
Pay: $23.00 - $27.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Professional development assistance
- Retirement plan
- Tuition reimbursement
- Vision insurance
Experience:
- Quality inspection: 2 years (Required)
Work Location: In person
