BethlehemRecruiter Since 2001
the smart solution for Bethlehem jobs

Quality Engineer

Company: OraSure Technologies
Location: Bethlehem
Posted on: February 22, 2021

Job Description:

Quality Engineer participates and supports activities in the Quality Assurance Department that ensure all goods manufactured and services provided by the Company meet the quality requirements of the Company, regulatory and notified bodies.Responsibilities* Evaluate Non Conformances, Customer Complaints, CAPAs. Identify corrective and preventive action; determine assignable root cause, complete failure investigations and follow up to corrective and preventive actions, ensuring adequate and timely closure.* Write and maintain procedures/processes relating to the Quality Management System.* Prepare and present quality reports, data and Key Performance Indicators to management for review. * Review/document Change Control Requests, ensuring compliance with cGMP and quality standard requirements. Follow-up on recommended actions. * Implement Key Performance Indicators. Review and monitor trends, communicating out-of-norm issues to department management. Contribute to and assist in providing quality system training Company wide.* Assist in ensuring departmental understanding and compliance with the requirements of cGMP as applied to the company's products and processes. * As needed, assist in providing training and support to other departments.* If assigned, manage and facilitate the complaint process. Perform and/or facilitate data collection/entry, investigation, closure, customer communication, and file storage for customer complaints.* If assigned, support regulatory compliance of the complaint system, including Medical Device Reporting, field action and other regulatory reporting as necessary.* Initiate improvements to the Quality management system, ensuring compliance to all relevant Quality Standards and Regulatory requirements.* Implement Key Performance Indicators. Review and monitor trends, communicating out-of-norm issues to department management. Contribute to and assist in providing quality system training Company wide.* Lead/participate in and support internal and external audit program, and/or other audits as needed. Ensure timely, accurate completion of audits.* Participate in the development, and maintenance of the Company's Quality System to meet the requirements of US FDA, 21CFR 820 QSR, 21 CFR 600 and 21 CFR 211 , IS09001 , EN46001, IS013485:2016, MDSAP, WHO and all other applicable quality and regulatory standards.* If assigned, support execution of quality processes such as Quality Board investigations, Recall execution, ownership of NCR and CAPA investigations, support of quality information systems to include document control, electronic batch records, NCR, CAPA, complaint handling software, calibration program.* Apply risk-based approach to the execution of the quality system (Understand business continuity, resiliency, prioritization, contingency planning and ability to use risk management tools).* Provide recommendations on adequate testing and inspection procedures, sampling and sample sizes for production processes, studies and investigations when required. * Support other departmental activities as requested by department management or designate.Qualifications* Demonstrated knowledge of Quality Management Systems.* Experience with internal and external audit processes (leading & performing).* Demonstrated knowledge of cGMPs, FDA regulations, and SO P's.* Demonstrated advanced computer skills - Microsoft Office preferred.* Excellent verbal, written and interpersonal skills, including the ability to conduct verbal presentations appropriate to the level of the audience.* Demonstrated success working in a team environment.* Ability to travel by car and/or plane, up to 10%. Additional travel may be required based on business need.* Direct experience with statistical techniques and associated software.* Lean Six Sigma Green/Black belt desired.* Certified Quality Auditor and/or Certified Quality Engineer desired.* Bachelors/Undergraduate Degree in quality or science discipline (chemistry, biology, microbiology or medical technology preferred) or Associates degree with minimum of 7 years' experience in a quality assurance/quality control discipline. Advanced degree/certifications desired.* Minimum of five (5) years progressively responsible experience in a drug manufacturing, medical device, or biologics industry in a direct Quality Assurance or Quality Engineering position.* Ability to view video display terminal images for extended periods of time - up to four (4) hours at a time.* Ability to operate a computer keyboard and calculator.* Ability to lift, tug, or pull up to fifty (50) pounds.* Ability to sit for extended periods of time - up to four (4) hours at a time.* Occupational exposure to blood borne pathogens.OraSure Technologies is an Equal Opportunity EmployerEOE/AA

Keywords: OraSure Technologies, Bethlehem , Quality Engineer, Engineering , Bethlehem, Pennsylvania

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Engineering Jobs

Gas Leak Survey Technician, Westchester County, NY
Description: Duties ul li Paid Training li Company Vehicle li Company Cell Phone li Starting Salary 18/hr or DOE Key Responsibilities and Critical Success Measures The Field Technician, Leak Survey conducts (more...)
Company: Heath Consultants
Location: White Plains
Posted on: 02/27/2021

Product and Design Test Engineer
Description: Siter-Neubauer Associates is currently conducting a search for Product and Design Test Engineer: Responsible for creating, developing documenting engine and component designs. Assures technical work (more...)
Company: Management Recruiters International, Inc.
Location: Harrisburg
Posted on: 02/27/2021

Mac Tools Seeking Mechanics - Technicians - Training Provided
Description: Build a Great Career and a Quality Life with Mac Tools.Feel the freedom and independence of working on your own, in a stress free environment - with no one to answer to, except yourself Join the family (more...)
Company: Mac Tools
Location: Levittown
Posted on: 02/27/2021

Civil Engineering Design Lead
Description: Join a global professional services leader. We are committed to solving the world's biggest challenges in the areas of water, energy and urbanization. GHD's Northeast Regional Engineering Design Organization (more...)
Company: GHD
Location: Harrisburg
Posted on: 02/27/2021

Engineering Intern (Utility Substation Design)
Description: Engineering Intern Utility Substation Design Location: Freeport State/Territory: Maine Department: Power Delivery Freeport Substation Group Description Engineering Intern Utility Substation Design (more...)
Company: POWER Engineers
Location: Freeport
Posted on: 02/27/2021

Vice President of Engineering - Lancaster, PA #1630
Description: Job Description br br Are you a high-energy, analytical, entrepreneurial, hard-working team player Have you had success leading and growing the software development team in the technology or EdTech (more...)
Company: The Renaissance Network, Inc.
Location: Lancaster
Posted on: 02/27/2021

Transmission Planning/Studies Engineer
Description: Power Engineers, Inc. is seeking mid- to senior-level Transmission Planning/Studies Engineers. This position is posted in multiple POWER office locations but may have the opportunity to work remotely (more...)
Company: POWER Engineers
Location: Freeport
Posted on: 02/27/2021

12B Combat Engineer - Construction and Engineering Specialist
Description: Combat Engineers are essential to mission success by assisting their fellow Soldiers in tackling unpredictable environments. As a member of an Army National Guard Combat Engineer team, you'll design (more...)
Company: Army National Guard
Location: West Orange
Posted on: 02/27/2021

Field Service Technician
Description: BUILD your career with a global, diversified company that provides market leading assessment capabilities and technology services to help clients around the world achieve their goals. br br LIVE your (more...)
Company: Scantron Corporation
Location: Harrisburg
Posted on: 02/27/2021

Network Engineer Level II
Description: We are an established IT Services firm looking to hire an energetic, motivated individual with strong interpersonal skills to provide onsite technical support to our clients desktops, servers, network (more...)
Company: Edutek, Ltd.
Location: White Plains
Posted on: 02/27/2021

Log In or Create An Account

Get the latest Pennsylvania jobs by following @recnetPA on Twitter!

Bethlehem RSS job feeds