Quality Control Technician I

Job Title:

Quality Control Technician I Department:

Quality Status:

Full Time:

Non-exempt Reporting To:

Quality Manager Position Purpose:

The Quality Control Technician I is responsible for ensuring that quality documentation and records follow internal requirements as well as ISO 13485 and applicable FDA requirements. This position will also be required to perform quality testing for the release of products.

Responsibilities:

Follow

ISO 13485

& applicable

FDA 21 CFR

Part 820/210/211 required documentation Perform Device History Record (DHR) review to ensure manufacturing documentation are accurate and complete Support and review Change Orders (i.e. change management) Perform and support lab investigations, if applicable Support manufacturing deviations and corrective and preventative actions (i.e. CAPA) Support and generate new and improved quality systems when needed Support customer communications Support and engage in risk management planning and reporting Support document control Support Supplier controls, perform first article inspections and perform other quality inspections as required Support product and process risk control measures (i.e. pFMEA, dFMEA risk evaluation) and risk management files (i.e. control plans, reports, safety profiles) Support the quality department design controls for new products Support equipment calibration and preventative maintenance Support and/or perform other duties as required Education, Qualifications & Experience Associates degree or technical degree preferred or equivalent experience Minimum 1-year of experience working in the medical device industry Minimally, understand and apply knowledge of

ISO 13485

2016 and

ISO 17025

2017. Ideally, experience working in an established FDA Quality System Regulation (QSR-21 CFR Part 820, 21 CFR Part 210/211) Experience working with contract manufacturing, chemistry manufacturing and capital equipment Familiar with engineering and/or analytical chemistry methodology Experience in assisting with test method validation, process validation and equipment validation Equipment preventive maintenance and calibration experience a plus Good laboratory practice (cGLP) and good manufacturing practice (cGMP) experience Analytical problem-solving skills with a demonstrated ability to resolve complex issues Ability to collect, summarize and report technical information Integrity and high ethical standards Computer competency in MS Office - Word, Excel and Outlook Excellent verbal, interpersonal and written communication skills Self-starter, and motivated individual who works independently and coach/mentor on best practices as needed Desire to learn and grow with company and help take the company to the next level

Authority:

To stop the production line due to non-conformance To ensure the effectiveness of laboratory activities To report to laboratory management on performance of the Quality Management System, and any need for improvement The laboratory staff shall be committed to impartiality and confidentiality, including not allowing commercial, financial, and other pressures to compromise impartiality

Working Conditions and Health & Safety:

Manual dexterity Ability to lift 40 lbs. Heated and air-conditioned office environment ISO Class 7 Cleanroom Environment Laboratory Employee is required to use appropriate PPE including, but not limited to, nitrile or latex gloves, lab coat, hair bonnet, shoe covers, beard cover, safety glasses, hearing protection, face shield, or respiratory mask while working in a lab or manufacturing space Harland Medical System's commitment to ensure employee health and safety is a priority. Personnel engaged in manufacturing shall obtain training required by

ISO 13485, FDA 21 CFR

part 820, FDA 21 CFR part 210 & 211, and Harland Medical System's internal procedures, where deemed appropriate per assigned job functions.

Job Type:

Full-time Pay:

$23.00 - $26.00 per hour

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Health savings account Life insurance Paid time off Parental leave Retirement plan Vision insurance

Education:

Associate (Preferred)

Experience:

Quality control: 1 year (Preferred)

DHR Review:

1 year (Preferred) Ability to

Commute:

Eden Prairie, MN 55344 (Required)

Work Location:

In person