Quality Control Technician II (2nd shift)

Quality Control Technician II (2nd shift) Harland Medical Systems Eden Prairie, MN Job Details Full-time $25•$28 an hour 11 hours ago Benefits Health savings account Health insurance Dental insurance 401(k) Paid time off Parental leave Vision insurance 401(k) matching Life insurance Retirement plan Qualifications Statistics Customer communication Microsoft Outlook Production data analysis Data analysis reporting ISO standards Quality control statistical data analysis Word processing Professional ethics Statistical Process Control Data reporting GMP Technical report writing Medical device manufacturing facility experience Problem-solving Quality control Cleanroom Biomedical regulatory compliance Manufacturing Associate's degree FDA regulations

Full Job Description Job Title:

Quality Control Technician II Shift:

2nd•4:00pm to 2:30am (Mon•Thurs)

Department:

Quality Status:

Full Time:

Non-exempt Reporting To:

Quality Supervisor/Quality Manager Position Purpose:

The Quality Control Technician II is an active member of cross-functional teams at Harland Medical Systems, responsible for designing, developing, manufacturing coating materials and coating equipment purchased by major medical device companies. The Quality Technician is expected to provide quality systems support and guidance throughout these team activities.

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, investigate and lead to resolve product and process nonconformities Support and lead manufacturing deviations and corrective and preventative actions (i.e. CAPA) Support and generate new and improved quality systems when needed Support and assist customer communications Support and engage in risk management planning and reporting Support document control Perform investigations of product, services or internal business processes in order to identify and correct issues causing non-compliance of product to specification Support external audits initiated by customers and regulatory agencies, and internal audits Support and assist with Supplier controls, perform first article inspections and perform other quality inspections as required Support the quality department design controls for all Quality Pathways 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:

Technical degree or equivilent experience in Engineering or Life Sciences Minimum 1-3 years 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 Analytical problem soling skills with a demonstrated ability to resolve complex issues Ability to collect, summarize, and report technical information Basic statistical analysis and interpretation of statistical data (i.e. SPC, population testing, confidence intervals) 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 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 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.

Physical Demands:

While performing the duties of this job, the employee is regularly required to sit and stand for prolonged period of time. The employee is frequently required to talk and hear; use hands to handle or feel; and reach with hands and arms above shoulder height and below the waist. Using proper lifting techniques, the employee must be able to lift up to 40 lbs.

Job Type:

Full-time Pay:

$25.00•$28.00 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: 3 years (Preferred)

DHR Review:

3 years (Preferred) Ability to

Commute:

Eden Prairie, MN 55344 (Required)

Work Location:

In person