Quality Assurance Engineer

$80k - $100k

Aegis Worldwide

Indianapolis, IN

Job Title: Quality Assurance Engineer

Industry: Medical Device Manufacturing

Location - Indianapolis, IN - near downtown

Pay: $80K - $100K, depending on experience

Schedule : Monday-Friday, 7AM-4PM / 8AM-5PM

Responsibilities:

Make sure production processes stay compliant with industry standards while working toward a company-wide ISO 13485 certification.
Develop and implement quality management system (QMS) documents.
Complete technical writing of SOPs, work instructions, and QMS processes, working within MasterControl eQMS.
Conduct audits with the quality team, preparing reports and data for these ahead of time.
Conduct analysis of manufacturing processes and products - charting quality issues within the QMS and implementing corrective actions.
Risk Management activities - risk analysis/FMEA and corrective actions
Manage nonconformances within the production process - pinpointing these and finding ways to rework the product or avoid the quality issue moving forward
Supplier quality - SCARs (supplier quality action requests) and auditing of suppliers to make sure quality standards are met.
Software validation activities - IQ, OQ, PQ
CAPAs and root cause analysis
R&D manufacturing - assisting with this and development of new products/processes
Train and develop quality associates
Participate in continuous improvement and safety projects with the engineering teams.

Required Qualifications :

Bachelor's degree in Engineering
5+ years of engineering / progressive quality experience leading to engineering
Must have medical device experience / experience with ISO 13485 regulations.
Experience working within a QMS system, preferably MasterControl eQMS but others are acceptable.
Experience writing technical instructions, SOPs, and QMS documents.
Experience with the following - CAPAs, root-cause analysis, FMEA, corrective action, and supplier quality action requests

Apply

Vacancy posted 3 days ago

Similar jobs that could be interesting for youBased on the Quality Assurance Engineer in Indianapolis, IN vacancy

Senior Quality Assurance Engineer
...Senior Quality Assurance Engineer T2 Systems is the largest parking, mobility, and transportation provider in North America, with more than 25 years in the parking management industry and currently serving thousands of parking professionals. We integrate the best people...
Suggested
For contractors
Work at office
Early shift
T2 Systems
Indianapolis, IN
2 days ago
Senior Quality Assurance Engineer
$169.27k - $232.2k
...Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open... ...Roche Diagnostics Operations, Inc. seeks a Senior Quality Assurance Engineer at its Indianapolis, IN location. Duties: Plan, design, develop...
Suggested
Local area
Remote work
3 days per week
F. Hoffmann-La Roche Ltd
Indianapolis, IN
4 days ago
Staff Quality Assurance Engineer
...advance human health for tomorrow. Learn about the Danaher Business System ( which makes everything possible. The Staff Quality Assurance Engineer is responsible for owning quality related processes, guiding cross-functional teams through Beckman’s quality management...
Suggested
Part time
Local area
Night shift
Danaher Corporation
Indianapolis, IN
6 days ago
Software Test Engineer
...Junior To Mid-Level Software Test Engineer Randstad Engineering is looking for a junior to mid-level software test engineer to join a machinery company in developing autonomous vehicle software in the Indianapolis, IN area. This would be developing and executing test...
Suggested
Samprasoft
Indianapolis, IN
4 days ago
Software Test Engineer
...System ( which makes everything possible. The Software Test Engineer is responsible for supporting the software engineering team by... ...scripts, and validating software functionality to ensure high quality releases. This position reports to the Lead Software Test Engineer...
Suggested
Part time
Danaher Corporation
Indianapolis, IN
3 days ago
QA/Testing Engineer
$54k - $58k
...Participates in the quality assurance (QA) activities of a project which may include test case, requirements and design reviews. Executes test events (test plan, test scripts, schedule management, test report, test event). Documents and debriefs team members on test results...
Contract work
Work at office
ASM Research, An Accenture Federal Services Company
Indianapolis, IN
3 days ago
Remote QA Engineer
...QA Engineer Apex Systems, a national leader in IT Solutions, is searching for a QA Engineer... ...the chance to influence healthcare data quality and better patient care through data and... ..., develop and maintain data quality assurance framework to test ETL jobs, Informatics...
Long term contract
Remote work
Software Technology Inc
Indianapolis, IN
3 days ago
Remote QA Engineer
...There is no evaluation framework, no regression baseline, no quality gate in CI/CD. A QA failure at a bank is not a user experience... ...evaluation framework, set up CI/CD gates, and triage bugs alongside engineering. The function gets built because you build it yourself. Once...
Live in
Remote work
GrabJobs
Indianapolis, IN
2 days ago
Remote Senior QA Engineer
As a Senior QA Engineer, you will be joining our product development team. This team is responsible for building and optimizing our main product. You will work on guarding the quality and stability of our main product with our scrum teams in Product Development. Our...
Remote work
Flexible hours
GrabJobs
Indianapolis, IN
2 days ago
Software Development Engineer in Test II
$95k - $171k
...scale? Join our Networks SQA team! Our Networks Software Quality Assurance (SQA) team ensures our global platform's reliability by... ...infrastructure for qualification testing and collaborate with Networks Engineering teams to validate network topologies. Using our expertise in...
Work experience placement
Worldwide
Akamai
Indianapolis, IN
2 days ago
Quality Assurance Engineer - Construction
...F.A. Wilhelm Construction – Quality Assurance Engineer Empowering People to Build What Matters - That is our mission and our legacy. Our nearly 100 years of building communities in which we work and play, started with one man and one dream. Today, we are a company...
Full time
Contract work
Temporary work
Work experience placement
For subcontractor
F.A. Wilhelm Construction Co., Inc.
Indianapolis, IN
19 hours ago
Quality Engineer I
...Description: Quality Engineer Pay rate ##### Agency Bill rate ##### 1st shift 8am-5pm 1. Lead Quality Assurance deliverables as assigned by plan product team, including the following examples: Special Product Characteristics (SPC) determination, Process...
Shift work
Day shift
Tricehealthcare
Indianapolis, IN
14 hours ago
Quality Engineering Senior
$92.2k - $115.3k
...their team in West Lafayette, IN, we are seeking a Senior Quality Engineer to help develop a world-class Quality function. The ideal candidate... ...supply chain functions Coordinate with external quality assurance auditors and technicians to ensure compliance Train...
Permanent employment
Temporary work
For contractors
Work experience placement
Casual work
Local area
Flexible hours
SAAB
Indianapolis, IN
2 days ago
Quality Engineering (Assembly / Manufacturing)
...person in this position will be responsible for implementing ATI quality policies and procedures in the manufacturing part fabrication... ...are unusual and difficult. High level of knowledge of product engineering and manufacturing/assembly processes. High level of...
Hourly pay
Temporary work
Immediate start
Worldwide
Dormont Manufacturing Company
Indianapolis, IN
4 days ago
Quality Engineering Manage
...Quality Management System Principal Responsible for ensuring compliance with established requirements and standards for products... ...school diploma or equivalent required. Bachelor's degree in Engineering preferred. Technical, engineering, and/or scientific background...
Work at office
Local area
Katalyst HealthCares & Life Sciences
Indianapolis, IN
4 days ago
Quality Engineer
...Company Overview: Nelson Global engineers, manufactures, and distributes clean and efficient Air & Fluid Transfer, NVH, Complex Structural... ...and technologies of the future. Position Overview: The Quality Engineer is responsible for supporting plant quality performance...
Work at office
Nelson Global Products
Indianapolis, IN
5 days ago
Quality Engineering S
...ampere individuals to join our team! Job Description The Quality Engineer will, under the general direction of the Quality Manager,... ...of handling day-to-day product and process quality assurance support. Working with the metrology lab team, including performing...
Contract work
Local area
Relocation
Enpower
Indianapolis, IN
14 hours ago
Manufacturing quality engineering
$95k - $105k
...Quality Engineer LHH is seeking a Quality Engineer for a direct hire, permanent placement position with a manufacturing client located... ...regulatory standards in regards to production quality, quality assurance, and supplier quality Create, maintain, and update...
Permanent employment
Immediate start
LHH
Indianapolis, IN
4 days ago
Sr Quality Engineer
$79k - $158k
...solutions such as temperature control, air quality and transportation, we improve lives,... ...oriented, and highly autonomous Senior Quality Engineer to join our team. Working as an... ...Flow, and Control Planstoidentifyrisks and assure product reliability during development and...
Hourly pay
Contract work
Temporary work
Work at office
Local area
Shift work
Day shift
Carrier
Indianapolis, IN
14 hours ago
Quality Engineering
...Summary: Provides statistical information for quality improvement by identifying testing methods and samples. Project... ...American society of quality control certified quality engineer qualification Contribute to team effort by accomplishing related...
Hourly pay
Oxford Global Resources
Indianapolis, IN
2 days ago
Manufacturing quality engineering
...Job Description The Quality Engineer position is responsible for ensuring that the products produced, and the manufacturing processes... ...Experience: Demonstrated working knowledge/experience in quality assurance discipline. Previous contract manufacturing experience...
Contract work
Work at office
Wabtec
Indianapolis, IN
5 days ago
Quality Engineer
...Indianapolis, IN - Pharma Services Group Discover Impactful Work The Quality Engineer is responsible for providing oversight for commissioning and... ...Process Improvement (PPI) program. Works with FCS sites to assure consistency in validation strategy/approach for local and...
Work experience placement
Work at office
Local area
Relocation package
Dormont Manufacturing Company
Indianapolis, IN
5 days ago
Quality Assurance/Engineering
...Insight Global is seeking a Quality Engineer to support one of our largest clients in Indianapolis. The QE acts as a cross-functional liaison between quality assurance, production, engineering, and program management to ensure compliance with internal procedures, customer...
Full time
Flexible hours
Insight Global
Indianapolis, IN
1 day ago
Quality Engineering S
...-moving company, we're building out our quality systems and processes to match the growth... ...business. We're looking for a Quality Engineer who is ready to roll up their sleeves, take... ...• Develop and implement quality assurance plans and requirements. • Conduct supplier...
Work at office
Aero Industries
Indianapolis, IN
3 days ago
Manufacturing quality engineering
...Quality Engineer GTC Machining has grown from a very humble beginning to a major supplier of machining and engineering services throughout the Defense, Aerospace, Medical Devices, and Commercial market segments. Our mission is to engage customers and empower makers...
Full time
Work at office
GTC Machining, LLC
Indianapolis, IN
4 days ago
Quality Engineering Manage
$100k - $150k
...Hanson Values Integrity | Commitment | Quality | Relationships | Innovation If you're looking for a firm that encourages innovative... ...and our environment. A Day in the Life of an Air Quality Engineer at Hanson Here's a snapshot of what you would do in this...
Internship
Local area
Hanson Professional Services, Inc.
Indianapolis, IN
5 days ago
Quality Engineering S
...procedures and practices to determine appropriate action. Monitor policies, procedures, and standards relating to Supplier Quality Engineering (i.e. metrics, data entry, log parts) Requirements ~ Bachelor's degree in an Engineering or Engineering Technology...
Contract work
Work at office
Monday to Friday
Shift work
LanceSoft
Indianapolis, IN
15 hours ago
Quality Engineer
...Quality Engineer What makes us strong? Our employees in 50 countries worldwide – all working with passion to enable high-tech applications with our strong metals: tungsten and molybdenum. Our Mi-Tech Tungsten Metals site in Indianapolis is home to a dedicated team...
Local area
Worldwide
Plansee Group
Indianapolis, IN
4 days ago
Manufacturing quality engineering
...Job Description Quality Engineer We are looking for a highly skilled Quality Engineer to develop, implement, and enforce quality... .... This role requires a strong background in quality assurance methodologies, root cause analysis, corrective actions, and...
Relocation package
Pivot Workforce
Indianapolis, IN
14 hours ago
Systems Test Engineer
...select group of organizations that go above and beyond in building exceptional workplace cultures. System Test / QA Validation Engineer - Indianapolis, IN Allegion is seeking a dedicated and experienced System Test / QA Validation Engineer to join our team. As a...
H1b
Allegion
Indianapolis, IN
5 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Quality Assurance Engineer. Be the first to apply!