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Quality Assurance Engineer III
1 month ago
Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.
Title: Quality Assurance Engineer III
Notes:
- 100% onsite.
- Working hours: 8am – 5pm (some flex, Kerry works 7am-4pm). There’s 2 shifts.
- Small site: 35-37 people, they make a class 2 med device (paper). Print shop that makes med devices.
- Sell VERY LARGE volumes of 1-1.5M devices each month. They are used to collect blood, dried, and can be shipped without a biohazard upcharge. Newborn testing, various other testing.
- Will manage root cause analysis, customer complaints, CAPA, validation, FMEA, calibrations & PMs, SW validation, involved in the design process (not a ton). They’ve developed 4, launched 3 in the last 10 years.
- Needs to be OK with auditors from ISO & FDA. Not the primary internal auditor, but when they get audited, this person will likely see OT.
- Communication is key – top level C-suite to the mfg. floor
- Needs to be data driven, presenting data supporting a position and convincing people it’s the correct thing to do, and work WITH the journeyman pressman to create a corrective action. (Some people don’t take the pressman seriously, but it’s literally the entirety of their job. They know how the machines work best.)
- Doesn’t need printing experience – needs a med device background.
- Need experience with Regulations: ISO 13485, ISO14971, Risk Management, registered in 80 countries, 21 CFR 820 and IVDR
- Needs to understand Risk and Corrective Actions related to the device – very important. Some people raise red flags over everything, and it’s not going to work with this particular device.
- Needs at least 3 years of experience.
- The Quality system is very well established. They only make 1 device. There isn’t a ton of opportunity for changes. They recently implemented a new printing press which required a whole validation, but it’s not heavy on technical writing.
- Med Device experience without Quality – will look at them. Accounting background, Reg Affairs, etc.
- Requires BS degree – if it’s a science degree, they aren’t going to use it. It’s not very technical what they do there. It’s steady work, not glamourous, it’s not state of the art, but it’s necessary and saves babies’ lives. They prefer to promote from within. Within 2 years, they would be moving into her positions. Very hands-on, will be on the floor working with the team.
Description:
- Designs, implements and maintains quality assurance protocols and methods for processing materials into partially finished or finished products.
- Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution.
- Designs methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products.
- Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
- May assure compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO, Six Sigma).
Education:
- BS degree or equivalent
Keywords:
- SIX SIGMA
