-
Quality Engineer
1 day ago
StaffBright Louisville, United StatesCurrently, StaffBright has a great Quality Engineer opportunity located in Louisville Kentucky. We are seeking individuals with at least 3+ years of experience · What You Will Be Doing · Support and actively participates in the APQP process for new product launch. · Lead problem ...
-
Quality Engineer
1 day ago
Peoplelink Staffing Solutions Louisville, United StatesQuality Engineer · Peoplelink Staffing Solutions in partnership with a prominent client in Louisville, KY within the construction industry. · Quality Engineer Job Summary: · $75,000 - $90,000 + 5% bonus · 8 - 5, Monday - Friday, minimal travel (generally day trips) · Ensure th ...
-
Quality Engineer
2 weeks ago
JobRialto Louisville, United States· Position Description · Senior Quality Engineer position will be inspecting product, researching and completing certification documentation for inspected product. This position will work in a team environment reviewing, inspecting and putting together certification packets of ...
-
Quality Engineer
2 weeks ago
Dant Clayton Corporation Louisville, United StatesJob Description · Job DescriptionJob Summary · The Quality Engineer will play a crucial role in ensuring that our ALS, welded deck, and press box products meet or exceed industry standards and customer expectations. The ideal candidate will have a strong background in quality con ...
-
Quality Engineer
1 week ago
Piston Automotive Louisville, United StatesOverview: · As a Quality Engineer, you will be responsible for planning and directing activities concerned with development, application, and maintenance of the quality operation system (QOS) for manufacturing processes, materials, and products. · Piston Automotive wasnt just f ...
-
Quality Engineer
3 weeks ago
Modine Manufacturing Company Louisville, United StatesAt Modine, we are engineering a cleaner, healthier world. Building on more than 100 years of excellence in thermal management, we provide trusted systems and solutions that improve air quality and conserve natural resources. More than 13,000 employees are at work in every corner ...
-
Manufacturing Quality Engineer
1 week ago
Acro Service Corp Louisville, United StatesJob Title: Quality Engineer · Duration 6 Months · Location: Louisville, KY · Pay Rate: $45-50/hr · Job Description: · The candidate will be responsible for developing quality plans, quality assurance procedures, performing layout work on applicable measurement equipment using Far ...
-
Quality Engineer
4 weeks ago
Staff Management | SMX New Albany, United StatesStaff Management | SMX is currently in search of a Quality Engineer for our client located in New Albany, IN. This is a direct hire position with benefits. Send over your resume to the RPS Recruiter at so that we can get you started · Perks & Benefits · Weekly paychecks · Direct ...
-
Quality Engineer II
2 weeks ago
BAE Systems Louisville, United States Full timeJOB DESCRIPTION · Job Description · How does it feel to work on a team driven to make a big impact? Empowering. · BAE Systems is seeking a quality professional to fill an immediate opening for a Quality Engineer in their Louisville, Kentucky location. In this role as a Quality ...
-
Senior Quality Engineer
4 days ago
Acro Service Corp Louisville, United StatesDuration- 06 Months · Job Title: Sr. Quality Engineer · Location: Louisville, KY · Pay rate: $44/hour · Note: Please send your updated resume if you want to get submitted. · Position Summary · Our client provider of some of the world's most advanced, technology-led defense, aero ...
-
Senior Quality Engineer
3 weeks ago
Amtec Inc. Louisville, United StatesThe Senior Quality Engineer position will be inspecting product, researching and completing certification documentation for inspected product. This position will work in a team environment reviewing, inspecting and putting together certification packets of product to present to g ...
-
Quality Engineer II
4 days ago
BD (Becton, Dickinson and Company) Louisville, United States**Job Description Summary** · The Quality Engineer II is responsible for ensuring TTM products are developed and released meeting customer expectation, regulatory requirements, appropriate standards, and BD policies and procedures. This position will work as a member of a TTM cr ...
-
Sr Quality Engineer
3 weeks ago
Alpha Consulting Louisville, United StatesJob Title : Sr Quality Engineer · Location : 1480 Arthur Ave, Unit D, Louisville Colorado 80027 · Duration : 12 Months · Job ID : 13212 · Pay rate: $45-$55/hr On W2 · Must Have · Equipment and Software Validation Experience · Nice To Have · Experience working in Medical D ...
-
Quality Engineer II
1 week ago
Apollo Professional Solutions Louisville, United StatesJob Description · Quality Engineer - US Citizenship Required by Client · Pay rate: $43.34 · Benefits: Healthcare Dental, Vision, 401k · Shift: Day, 9/80 workweek (every other Friday off) · Quality Engineer - JOB DESCRIPTION:Client is seeking a quality professional to fill an imm ...
-
Senior Quality Engineer
6 days ago
Reynolds Consumer Products Inc. Louisville, KY, United StatesWe currently have an opportunity for a Senior Quality Engineer to join our team located in Louisville, KY. · The Senior Quality Engineer is responsible for inspecting manufacturing processes to ensure that the finished product will comply with quality standards. The Senior Quali ...
-
Quality Engineer
1 week ago
SIMOS New Albany, United States· Staff Management | SMX is currently in search of a Quality Engineer for our client located in New Albany, IN. This is a direct hire position with benefits. Send over your resume to the RPS Recruiter at [email protected] so that we can get you started · Perks & BenefitsWeekly ...
-
Quality Engineering Manager
3 weeks ago
Samtec Inc New Albany, United StatesFounded in 1976, Samtec is a privately held, $1B global manufacturer of a broad line of electronic interconnect solutions, including High-Speed Board-to-Board, High-Speed Cables, Mid-Board and Panel Optics, Precision RF, Flexible Stacking, and Micro/Rugged components and cables. ...
-
Quality Engineer
3 weeks ago
JobRialto Louisville, United States:Client, Combat Mission Systems, is seeking a quality professional to fill an immediate opening for a Quality Engineer in their Louisville, Kentucky location. In this role as a Quality Engineer, you will be responsible for supporting several products within a given program area/m ...
-
Quality Engineer
4 weeks ago
Advantage Technical Louisville, United StatesJob Title: · Quality Engineer · Job Location: · Louisville, KY · Hourly Rate: Up to · $44.58/hr · depending on experience. · Work Schedule: 9/80 work week - · off every other Friday · Summary: · Come join our team We currently have an exciting possible · Temp-to-Perm ...
-
Quality Engineer
2 weeks ago
JobRialto Louisville, United StatesPosition Description Senior Quality Engineer position will be inspecting product, researching and completing certification documentation for inspected product. This position will work in a team environment reviewing, inspecting and putting together certification packets of produc ...
Senior Quality Engineer - Louisville, United States - Integra LifeSciences
Description
Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare.
As the Senior Quality Engineer for a medical device manufacturer, this position is primarily responsible for assuring compliance to all regulatory requirements.
This position will support Quality operations for Louisville, KY Distribution Center; NC, CAPA, inspections, audits, and complaints at a minimum.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Other duties may be assigned.
Develop, review, and approve quality records, including daily inspections, plans, protocols, and reports, supporting GxP manufacturing and development.
Work in partnership with the 3PL to ensure all activities and operations are carried out in compliance with local, state, federal, and international regulations and laws governing the quality operations.
Perform Quality Investigations in response to quality events (complaints, HHE), use good judgement and a systematic approach to identify root cause and determine appropriate corrections, implement corrective and preventive actions, and keep good records to for traceability.
Responsible for providing quality documentation as requested by external customers. This includes but not limited to quality certificates, as well as test reports where appropriate
Responsible for the collection and reporting of metrics and data to Division, Facility and Department Management per defined schedules or ad hoc when required to communicate involvement and results of quality engineering activities.
Other Duties as assigned.
QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill and/or ability required for his position.
Education :
Bachelor's degree in a scientific, engineering, or equivalent discipline with 7 years of experience in a regulated industry.
Experience :
Prior experience with Medical Devices and Instruments is required.
Strong analytical skills, exceptional writing, and interpersonal relationship skills
Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments.
Able to coordinate and lead cross-functional activities.
Compiles and analyzes data, identifies causes, draws conclusions, generates reports.
Uses expertise to improve operational efficiencies and meet compliance requirements.
Demonstrated knowledge of FDA regulations, applicable medical device/quality system ISO standards, CMDR, MDD and other national and international regulations and standards.
Strong statistical analysis skills.
Solid organizational and document management skills
Strong working knowledge Microsoft Office programs (Word, Excel, Access, PowerPoint).
Experience working in Oracle, Agile and TrackWise systems preferred.
Continuous Improvement experience is preferred.
Must be able to work independently with minimal supervision.
Must be able to read and write in English.
Must be able to demonstrate comprehension of written English by successfully completing unassisted written tests, including, but not limited to, Work Instructions and Standard Operating Procedures.
Must be able to observe company policies and safety procedures at all times.Must be able to give and welcome constructive feedback; contribute to building a positive team spirit.
Must be able to treat others with respect; work with integrity and ethically; uphold organizational values.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law
|
EOE including Disability/Protected Veterans
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the
ADA
. If you have difficulty using our online system due to a disability and need an accommodation, please email us at
or call us at
Integra - Employer Branding from Integra LifeSciences on Vimeo
#J-18808-Ljbffr