33 Jobs in grand rapids, mi
Praxis Packaging Solutions is Hiring a Quality Engineer Near Grand Rapids, MI
The Quality Engineer is responsible for compliance with the requirements of 21CFR Parts 110/111 and 210/21, 820, 1300. This position works closely with the Quality Managers and other internal department Managers and Supervisors at Praxis to release processes for our equipment, plans and executes regular equipment protocols for new product launches. This position works with all supervision and employees to ensure that cGMPs and Praxis SOPs, policies and work instructions are being followed.
- Reports and validates activities to ensure cGMP regulations and industry standards
- Independently and indirectly manages and guides cross functional teams to assess and investigate operational deviations. Ensures comprehensive investigations are documented including a risk assessment, root cause, corrective and preventative action plan.
- Maintains and effective liaison and corporative relationship with other Quality areas and departments
- Validates quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures
- Reviews and approves qualification protocols
- Revies and approves cleaning validations
- Reviews any validation investigation deviations
- Manages temperature monitoring system pertaining to product compliance
- Oversees GMP utility systems for QA review and approval
- Manages Change Control Committees and process meetings
- Communicates directly with customers when needed
- Performs Internal and Supplier audits
- Supports customer audits
- Authors, assigns and manages Compliant, Corrective and Preventive Action Deviation activities
- Reviews calibration status and records compliance as applicable per SOP.
- Drafts, reviews and organizes Quality Systems Policies, SOPs, WIs and Forms
- Responsible for adherence to all Company policies and procedures
- Works to improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions
- Addresses complaints and problems, elevates to Leadership when needed
- Ensures proper PPE’s and Safety procedures are followed
- Instills a sense of quality through modeled quality behaviors and mindset
- Flexibly works other shifts, shifts maybe 8, 10 or 12 hours as needed
- Able to coach and mentor others in technical areas
- Performs any other functions and duties assigned and necessary for the smooth and efficient operation of Praxis Packaging Solutions.
- Bachelor’s degree in an Engineering required
- 2-5 years of experience working in Quality or Engineering role in manufacturing environment required
- Knowledge of quality/compliance management as well as regulations and standards required
- Demonstrated experience with quality systems in a FDA cGMP regulated environment, including experience with investigations and/or developing and recommending processes improvements required
- Working knowledge of MS Office programs Word, Excel, and Outlook, required
- Working knowledge of Enterprise Resource Planning (ERP) related software, preferred
- Working knowledge of QMS Software Systems (TrackWise, ETQ, Intellex etc..), strongly preferred
- Ability to speak and understand English in a manner that is sufficient for effective communication with supervisors, employees, and customers to include reading and writing skills to understand and complete necessary customer paperwork, required
Job Summary
Full Time
$93k-111k (estimate)
06/20/2024
07/07/2024
praxispackaging.com
GRAND RAPIDS, MI
100 - 200
1989
WILLIAM OCKERLUND
$10M - $50M
Related Companies
About Praxis Packaging Solutions
Praxis is an FDA compliant, solutions-driven Contract Packaging company specializing in Secondary finished goods packaging for the pharmaceutical, consumer goods, food and nutritional industries. Praxis also specializes in primary bottling for oral solid dosage form pharmaceuticals. At Praxis, we don't just deliver innovative, turnkey finished goods packaging solutions. We provide them while exceeding our customers' expectations, managing their critical deadlines, and upholding rigorous regulatory and quality standards. Regulatory & Compliance: * Serialization ready * (US FDA) Food & Drug Admi ...
nistration * (US DEA) Drug Enforcement Agency * (DoA) Department of Agriculture in both MI and OH * Experience obtaining Kosher certification * Hazard Analysis & Critical Control Points (HACCP) trained * Agile response to new FDA guidelines, marketing requirements, regulations
More
Show Less
The job skills required for Quality Engineer include Quality Assurance, Problem Solving, Leadership, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Engineer. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Engineer. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Quality Engineer positions, which can be used as a reference in future career path planning. As a Quality Engineer, it can be promoted into senior positions as a Quality Assurance Engineer IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Engineer. You can explore the career advancement for a Quality Engineer below and select your interested title to get hiring information.
Similar Jobs
Popular Articles
