Quality Engineer - Frederick, United States - Medix

Medix Frederick, United States

3 weeks ago

Pharmaceutical / Bio-tech

Description

We are seeking a talented Senior Quality Engineer with biologics experience ensure that the highest standards of quality and compliance are met for our organization. This position will play a pivotal role in establishing and maintaining robust quality systems and processes to support our first-ever clinical trials through to our manufacturing processes. Working closely with cross-functional teams, this person will be responsible for implementing quality standards, conducting risk assessments, and driving continuous improvement initiatives to ensure compliance with regulatory requirements and industry best practices.

RESPONSIBILITIES:

Establish quality systems/policies related to OOS, Deviations, CAPAs, NCMRs, and Complaints and work with various departments to ensure timely closure of related investigations.
Document deficiencies, including root cause, corrective and preventive action plans.
Ensure action plans are implemented in a timely manner.
Support from a quality perspective, analytical test method qualification plans/protocols and reports.
Assist with risk analysis activities and maintaining up to date risk management documents.
Establish Quality Inspection Plans for the release of components, assemblies, and finished devices.
Conduct quality inspections as needed.
Support Manufacturing and R&D/Product Development, Analytical Development and Quality Control with statistical techniques, including design of experiments (DOE); sampling plans and data/ results analysis.
Perform supplier evaluations as needed to assure supplier capabilities including the assessment of the adequacy of inspection methods, manufacturing practices, and control and quality procedures to deliver conforming products in a timely manner.
Lead supplier audits and works with suppliers to resolve audit findings and/or nonconformances.
Perform internal audits as needed.
Responsible for quality engineering review of Document Change Orders.
Set requirements for raw material or intermediate products for suppliers and monitor their compliance.
Ensure adherence to regulatory requirements, and health and safety guidelines.
Supervise inspectors, technicians and other staff and provide guidance and feedback.
Quality oversite on all product development procedures to identify deviations from quality standards.
Quality oversite on all product manufacturing processes and systems
Quality oversite on all manufacturing output and ability to compare properties to requirements.
Quality oversite on the sterilization and product release processes.

QUALIFICATIONS:

Minimum of a BS in Biomedical Engineering, Chemical Engineering, Biochemistry, Chemistry or equivalent degree.
5+ years relevant experience in Biologics/ Pharmaceutics. Experience in medical devices or combination products is a plus.

Senior Quality Engineer

3 weeks ago

Theradaptive Frederick, United States

Theradaptive is revolutionizing the field of therapeutic delivery with a pipeline of best-in-class products that address multiple global markets. Theradaptive is performing cutting edge science in the area of regenerative medicine, working at the interface of Biology and Orthoped ...
Quality Engineer

2 weeks ago

Medix Frederick, United States

We are seeking a talented Senior Quality Engineer with biologics experience ensure that the highest standards of quality and compliance are met for our organization. This position will play a pivotal role in establishing and maintaining robust quality systems and processes to sup ...
Quality engineer

3 weeks ago

Eclipse Innovations Leesburg, United States

Our client is a renowned and internationally operating company in the aircraft parts manufacturing industry. On their behalf, we are looking for a Quality Engineer (m/f) for a DIRECT HIRE position. · Your responsibilities: · • You ensure compliance with EASA Part 21G, EASA P ...
Sr Quality Engineer I

1 week ago

Gilead Sciences Frederick, United States

For Current Kite Pharma Employees and Contractors: · Please log onto your Internal Career Site $) to apply for this job. · At Kite, we empower our leaders to step up, share ideas, listen, learn, and lead. We're welcoming bright, diverse, and imaginative minds; we're nurturing the ...
Quality Assurance Engineer

2 days ago

LINCHPIN SOLUTIONS INC Frederick, United States

Job Type · Full-time · Description · If you are looking for an exciting career opportunity in the IT, engineering, software development, logistics, and project management fields, Linchpin Solutions is the place to be We are currently hiring for a dynamic and experienced Quality ...
Senior Quality Engineer

1 week ago

Theradaptive Frederick, United States

Theradaptive is revolutionizing the field of therapeutic delivery with a pipeline of best-in-class products that address multiple global markets. Theradaptive is performing cutting edge science in the area of regenerative medicine, working at the interface of Biology and Orthoped ...
Quality Assurance Engineer

1 day ago

LINCHPIN SOLUTIONS INC Frederick, United States

Job Type Full-timeDescriptionIf you are looking for an exciting career opportunity in the IT, engineering, software development, logistics, and project management fields, Linchpin Solutions is the place to be We are currently hiring for a dynamic and experienced Quality Assurance ...
Senior Quality Engineer

3 weeks ago

Theradaptive Frederick, United States

Theradaptive is revolutionizing the field of therapeutic delivery with a pipeline of best-in-class products that address multiple global markets. Theradaptive is performing cutting edge science in the area of regenerative medicine, working at the interface of Biology and Orthoped ...
Software Quality Engineer

2 weeks ago

Orases Frederick, United States

Summary: · The Software Quality Engineer (SQE) · is responsible for ensuring the quality and reliability of software and systems. · Working in close collaboration with development teams to understand software goals and requirements, the SQE will create testing strategies and p ...
Sr Quality Engineer I

3 weeks ago

Gilead Sciences, Inc. Frederick, United States Paid Work

For Current Kite Pharma Employees and Contractors: · Please log onto your Internal Career Site $) to apply for this job. · At Kite, we empower our leaders to step up, share ideas, listen, learn, and lead. We're welcoming bright, diverse, and imaginative minds; we're nurturing the ...
Quality Engineer

4 hours ago

EchoStar Germantown, United States Full time

Today, our brands include EchoStar, Hughes, DISH TV, Sling TV, Boost Infinite, Boost Mobile, DISH Wireless, OnTech and GenMobile. · EchoStar has an exciting opportunity for Quality Engineer in our Hughes Network Systems division. This position is located in our Germantown, MD ...
Electrical engineer in quality assurance

1 week ago

Crimson Technologies Rockville, United States

Rockville Electrical Engineer in Quality Assurance (m/f/d) · With room for your own ideas, modern working methods, a respectful environment, and a sustainable company culture, we are currently seeking an Electrical Engineer in Quality Assurance (m/f/d) to join our team at the ear ...
Civil Engineer Water Quality

3 weeks ago

Jobot Frederick, MD, United States Part time

This is a permanent position, offering an excellent opportunity to engage in challenging and innovative projects. The successful candidate will primarily focus on hydrology and infrastructure development, including water and sewer systems. This role is perfect for a professional ...
QA Specialist

2 weeks ago

Cartesian Therapeutics Frederick, United States

**Summary**: · The QA Specialist reporting to Senior Director, QA will support manufacturing operations from clinical to commercial day to day, reviewing batch records, review documents for manufacturing teams to resolve issues and ultimately review and release batches. This pers ...
Associate Scientist I

3 weeks ago

AstraZeneca Frederick, United States

Join our Operations team as an Associate Scientist I / II in the MS&T Labs. The core responsibilities of this role include laboratory executions supporting large-scale investigations, raw material screening, and process optimization. The primary focus of this position will be ups ...
Assembler I

3 weeks ago

Spectrum Control Frederick, United States

At Spectrum Control, most departments operate on a 4-day, 10-hour work schedule in exchange for a 3-day weekend. We offer competitive wages and PTO, plus our benefits begin on day 1 of employment. Come join a workforce where we put you first · An Assembler 1 has the ability to in ...
Project Manager

2 weeks ago

WG/Welch Mechanical Contractors Frederick, United States

W.G./Welch Mechanical Contractors, LLC is a client-oriented mechanical contractor that provides first class plumbing, heating, and air conditioning services within the immediate Maryland-Virginia-Washington D.C. metropolitan area. · **Position Summary**: · Project Managers will o ...
Training Program Manager, QA

2 weeks ago

Cartesian Therapeutics Frederick, United States

**Summary**: · The Training Program Manager, QA reporting to the Senior Director, QA primary role will be to manage and build a training program for the Company. This person will be highly organized and enjoy teaching others and possess and demonstrate a customer service approach ...
Construction Project Manager

3 weeks ago

WG/Welch Mechanical Contractors Frederick, United States

W.G./Welch Mechanical Contractors, LLC is a client-oriented mechanical contractor that provides first class plumbing, heating, and air conditioning services within the immediate Maryland-Virginia-Washington D.C. metropolitan area. · **Position Summary**: · Project Managers will o ...
Manager, Qc

3 weeks ago

Thermo Fisher Scientific Frederick, United States

When you join the team at Thermo Fisher Scientific, you become part of a company that is dedicated to making a positive impact on the world. We are passionate about finding cures for cancer, protecting the environment, and ensuring the safety of our food. Your work as a Quality C ...