- Medical, dental, and vision benefits
- Company-paid life insurance and disability benefits
- Generous Paid Time Off and 10 paid Holidays
- 401k Plan with Company Match
- Tuition Reimbursement
- Career growth and opportunity for advancement
- Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
- Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
- Monitors manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained.
- Leads and implements various product and process improvement methodologies.
- Review the adequacy and correctness of changes to Bill of Materials (BOM's), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
- Leads in the completion and maintenance of risk analysis.
- Leads generation and completion of protocols and reports for test method validations.
- Interfaces with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable.
- Develops various inspection techniques and procedures to ensure product integrity to design specifications.
- Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures.
- Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.
- Leads and manage complaint investigations.
- Acts as a lead in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
- Assists with product transfers.
- Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems. Also, leads each of these groups with capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc.
- Coordinates and leads the preparation of Quality Plans, including inspection, test and gauge requirements for new product introductions.
- Provides support to other quality engineers.
- Performs other functions as required.
- Manage a heavy workload while maintaining accuracy.
- Identify potential roadblocks and provide innovative solutions.
- Operate with a high level of integrity and professionalism.
- Committed to and accountable for achieving goals and objectives.
- Bachelor's Degree in Engineering or related field required or 2-5 years of experience working in a quality engineering role within a regulated industry.
- 2-5 years' experience in medical device or regulated manufacturing
- Leadership in Quality Assurance principles in regulated industries
- Ability to multitask, lead, and drive initiatives to completion
- Competence in the selection and use of Quality Engineering Tools and Techniques.
- Strong communication skills and ability to align with key stakeholders
- Strong working knowledge in the interpretation and application of relevant Domestic and
- International Regulations and Industry Standards (e.g. FDA 21CRF820, ISO 13485:2016;
- MDSAP; ISO14971, QSR, MDD, TGA etc.)
- Proficient in Microsoft Office and Minitab
- Light work: Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or lift, carry, push, pull, or move objects.
- Visual Acuity: Close vision.
- Pay Type Salary
- Travel Required No
-
Quality Engineer
5 days ago
Plexus Buffalo Grove, United States Full timeWHO WE ARE · We're a global team of over 20,000 engineering, manufacturing, supply chain and sustaining service experts who partner with customers to bring their products to life through inspired innovation and world-class customer service. · From surgical devices and health mo ...
-
Quality Engineer
2 weeks ago
Dynomax Inc. Arlington Heights, United StatesQUALITY ENGINEER · Dynomax, Inc is expanding We are adding brand new, state of the art CNC Machines. With the additional machines and projects, maintaining quality is a priority. The Quality Engineer will be responsible for driving 6-Sigma projects, as well as other functions. Qu ...
-
Senior Quality Engineer
1 week ago
Argon Medical Devices Wheeling, United StatesCompany Overview:: · Argon Medical is a global manufacturer of specialty medical products, headquartered in Plano, Texas. Argon offers a broad line of medical devices for Interventional Radiology, Vascular Surgery, Interventional Cardiology and Oncology. Argons brand is recogniz ...
-
Quality Engineer
1 week ago
Katalyst Healthcares and Life Sciences Arlington Heights, United StatesResponsibilities: Participate in global quality engineering activities in software product development, manufacturing, and support including engineering design review, verification/ validation activities. · ble to define design document requirements for process and test method v ...
-
Quality Engineer
6 days ago
Dynomax Arlington Heights, United StatesQUALITY ENGINEER · Dynomax, Inc is expanding We are adding brand new, state of the art CNC Machines. With the additional machines and projects, maintaining quality is a priority. The Quality Engineer will be responsible for driving 6-Sigma projects, as well as other functions. Qu ...
-
Quality Engineer
1 week ago
Dynomax Inc. Arlington Heights, United StatesQUALITY ENGINEER · Dynomax, Inc · is expanding We are adding brand new, state of the art CNC Machines. With the additional machines and projects, maintaining quality is a priority. The · Quality Engineer · will be responsible for driving 6-Sigma projects, as well as other functio ...
-
Quality Engineer
1 week ago
Intertek Arlington Heights, United StatesJob Description · We are seeking a Quality Engineer to join our Business Assurance team. This will be a full-time remote/home-based position. Duties: - Technical review of aerospace reports, data, and records, both in iEnable and OASIS. - Responsible for certificate review and i ...
-
Quality Engineer
1 week ago
Intertek Arlington Heights, United StatesJob DescriptionWe are seeking a Quality Engineer to join our Business Assurance team. This will be a full-time remote/home-based position. Duties: - Technical review of aerospace reports, data, and records, both in iEnable and OASIS. - Responsible for certificate review and issue ...
-
quality engineer
3 weeks ago
Dynomax Wheeling, United StatesQUALITY ENGINEER · Dynomax, Inc · is expanding We are adding brand new, state of the art CNC Machines. With the additional machines and projects, maintaining quality is a priority. The · Quality Engineer · will be responsible for driving 6-Sigma projects, as well as other fun ...
-
Quality Engineer
2 weeks ago
ESPO Wheeling, United StatesJob Title: Quality Engineer · Location: Wheeling, IL · Job Type and Duration: 6 mos+ (potential contract to hire) · Summary: · • Plans and conducts activities concerned with the quality assurance of industrial processes, materials, and products by performing the following duties. ...
-
Quality Engineer
2 weeks ago
Aurora Ventures Cook, United StatesConnecting people and technologies, creating the perfect match for our clients, and always finding the right experts for each challenge - that is our goal at FERCHAU and we are looking for you: an ambitious colleague who, like us, wants to take technologies to the next level. We ...
-
Supplier Quality Engineer
5 days ago
Old World Industries Northbrook, United StatesPOSITION PURPOSE: Lead the investigation and continuous improvement of our global supplier base and manufacturing processes within multiple chemical production facilities. Work with a group to support continuous improvement projects while integrating ISO and IATF compliance into ...
-
Quality Engineer
2 weeks ago
Nemera Buffalo Grove, United States Full timeCompany Description · Nemera is a world leader in the design, development, and manufacturing of drug delivery devices for the pharmaceutical, biotechnology, & generics industries. With locations worldwide, some of our services and products include eyedroppers, pumps, valves, inha ...
-
Associate Quality Engineer
1 week ago
Medline Industries Arlington Heights, United StatesEducationTypically requires a Bachelor%26rsquo;s degree in Engineering, Science, Math or other related technical field. · Knowledge / Skills / AbilitiesExperience in processing all relevant details, understanding and prioritizing their importance, and drawing clear and concise co ...
-
Quality Engineer II
1 week ago
Viant, Inc. Wheeling, United StatesNew employees are eligible for the following benefits effective date of hireMedical, dental, and vision benefitsCompany-paid life insurance and disability benefitsGenerous Paid Time Off and 10 paid Holidays401k Plan with Company MatchTuition Reimbursement Career growth and opport ...
-
Quality Engineer
2 weeks ago
Sterling Engineering Elk Grove Village, United StatesTitle: Quality Engineer · Location: Elk Grove Village, IL · Compensation: $85-95K/year · Hire Type: Direct Hire · Job Summary: · We are looking for a Quality Engineer to join our team in Elk Grove Village, IL. This role involves ensuring product quality and compliance through eff ...
-
Quality Engineer II
3 weeks ago
Viant, Inc. Wheeling, United StatesNew employees are eligible for the following benefits effective date of hire · Medical, dental, and vision benefits · Company-paid life insurance and disability benefits · Generous Paid Time Off and 10 paid Holidays · 401k Plan with Company Match · Tuition Reimbursement · Career ...
-
Supplier Quality Engineer
1 week ago
Old World Industries Northbrook, United StatesPOSITION PURPOSE: Lead the investigation and continuous improvement of our global supplier base and manufacturing processes within multiple chemical production facilities. Work with a group to support continuous improvement projects while integrating ISO and IATF compliance into ...
-
Supplier Quality Engineer II
1 week ago
Phantom Staffing Lincolnshire, United StatesAbout the job Supplier Quality Engineer II · Essential Duties and Responsibilities: · Strategically lead supplier performance improvement projects in an effort to increase the supplier capability of consistently meeting requirements. Projects may include: process analysis, val ...
-
Senior Quality Engineer
1 week ago
Argon Medical Devices Wheeling, United StatesCompany Overview:: · Argon Medical is a global manufacturer of specialty medical products, headquartered in Plano, Texas. Argon offers a broad line of medical devices for Interventional Radiology, Vascular Surgery, Interventional Cardiology and Oncology. Argons brand is recogniz ...
Quality Engineer II - Wheeling, United States - Viant, Inc.
Description
New employees are eligible for the following benefits effective date of hireThe primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance.
Responsibilities:
Adheres to Viant Core Beliefs and all safety and quality requirements including, but not limited to:
Education/Certification
