- Adheres toInteger Core Beliefs and all safety and quality requirements including, but not limited to: 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.
- Effectively communicate and interact with customers. 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.
- Provides support to other quality engineers.
- Performs other functions as required.
-
Manufacturing Engineer III
2 days ago
Integer Holdings Salem, VA, United StatesBy living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. · At Integer, our values are embedded in everything we do. · Customer · We focus on our customers' s ...
-
Continuous Improvement Engineer III
8 hours ago
Integer Holdings Corporation Salem, United StatesContinuous Improvement Engineer III page is loaded · Continuous Improvement Engineer III · Apply · locations · Salem, VA · time type · Full time · posted on · Posted 4 Days Ago · job requisition id · R25750 · By living according to a common set of values, we create a c ...
-
NPI Quality Engineer III
8 hours ago
Integer Holdings Corporation Salem, United StatesBy living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. · At Integer, our values are embedded in everything we do. · Customer · We focus on our customers' su ...
-
Quality Engineer III
8 hours ago
OSI Jobs Roanoke, United StatesJob Title: Quality Engineer IIICompany: Publicly-traded, global Medical Device manufacturerLocation: Roanoke, VA. Relocation assistance available. Compensation: $100k - $115k + 8% bonusJob Summary: The Quality Engineer III will provide support for operations to ensure that the Qu ...
-
Electrical Engineer III
8 hours ago
AECOM Roanoke, United StatesJob Description · AECOMis seeking a creative and highly talentedElectrical Engineer III - Federalfor immediate employment in theRoanoke, VAoffice. · POSITION REQUIREMENTS: The responsibilities of this position include, but are not limited to: · Leading or assisting with the elect ...
-
Quality Engineer III
5 days ago
OSI Jobs Roanoke, United StatesJob Description · Job DescriptionJob Title:Quality Engineer III · Company: Publicly-traded, global Medical Device manufacturer · Location:Roanoke, VA. Relocation assistance available. · Compensation:$100k- $115k + 8% bonus · Job Summary:The Quality Engineer III will provide suppo ...
-
Electrical Engineer III
2 days ago
AECOM Roanoke, United StatesCompany Description · Work with Us. Change the World. · At AECOM, we're delivering a better world. Whether improving your commute, keeping the lights on, providing access to clean water, or transforming skylines, our work helps people and communities thrive. We are the world's tr ...
-
Electrical Engineer III
3 days ago
AECOM Roanoke, United States**Company Description** · **Work with Us. Change the World.** · At AECOM, we're delivering a better world. Whether improving your commute, keeping the lights on, providing access to clean water, or transforming skylines, our work helps people and communities thrive. We are the ...
-
System Administrator
9 hours ago
Crescens Salem, United StatesJob Title: System Administrator · Location: Salem, VA · Duration: 6+ Months · Note:Local Salem, VA candidates required · ALL interviews conducted ONSITE 100% ONSITE work and rotating on-call schedule. · Job Description: · The System Administrator is responsible for effective ...
-
Installer III
1 day ago
MasTec Inc. Roanoke, United StatesOverview · At MasTec Communications Group we build for the future. Yours and ours. · As an Installer III, you will develop new skills, work in a safety-minded environment, and join us in expanding technology for a better community. Join the MasTec family and help us provide the h ...
-
Facility Maint. Mechanic III
2 days ago
Carillion Health System Roanoke, United States" · Facility Maint. Mechanic III - Carilion Property Maintenance Rehab 1 Riverside · Roanoke, VA, US, 24016 · Employment Status: Full time · Shift: Day · Facility: Carilion Clinic - 1 Riverside · Requisition Number: 141680 · How You'll Help Transform Healthcare: · Experienced Mai ...
-
Program Subcontracts Manager III
4 days ago
Elbit Systems Roanoke, United StatesProgram Subcontracts Manager III - Merrimack, NH (REF1237R) · Full-time · Elbit Systems of America is a leading provider of high performance products, system solutions, and support services focusing on the defense, homeland security, commercial aviation, and medical instrumentat ...
-
Program Subcontracts Manager III
8 hours ago
Elbit Systems Roanoke, United StatesProgram Subcontracts Manager III - Charleston, SC (REF1237R) · Full-time · Elbit Systems of America is a leading provider of high performance products, system solutions, and support services focusing on the defense, homeland security, commercial aviation, and medical instrumenta ...
-
Program Subcontracts Manager III
8 hours ago
Elbit Systems Roanoke, United StatesProgram Subcontracts Manager III - Fort Worth, TX (REF1237R) · Full-time · Elbit Systems of America is a leading provider of high performance products, system solutions, and support services focusing on the defense, homeland security, commercial aviation, and medical instrumenta ...
-
Program Subcontracts Manager III
6 days ago
Elbit Systems of America Roanoke, United StatesProgram Subcontracts Manager III - Roanoke, VA (REF1237R) · 3 weeks ago · Be among the first 25 applicants · Company Description · Elbit Systems of America is a leading provider of high performance products, system solutions, and support services focusing on the defense, homel ...
-
Account Manager
5 days ago
Regal Rexnord Corp Radford, United StatesSUMMARY · In this specific role, the Area Sales Manager (ASM) will drive revenue and sales funnel growth with direct customers within their assigned territory for Kollmorgen branded products. The ASM will assume some established customers and be responsible developing opportunit ...
-
Machinist - 2nd Shift
16 hours ago
Regal Rexnord Radford, United StatesPosition Summary: The Machinist is responsible for operating machine tools to produce precision metal parts. This position is part of the Kollmorgen team in Radford, VA. Kollmorgen is part of Altra.Essential Duties and Responsibilities:To perform this job successfully, an individ ...
-
Machinist - 2nd Shift
6 days ago
Regal Rexnord Radford, United StatesPosition Summary: The Machinist is responsible for operating machine tools to produce precision metal parts. This position is part of the Kollmorgen team in Radford, VA. Kollmorgen is part of Altra.Essential Duties and Responsibilities:To perform this job successfully, an individ ...
-
Account Manager
5 days ago
Regal Rexnord Radford, United StatesSUMMARYIn this specific role, the Area Sales Manager (ASM) will drive revenue and sales funnel growth with direct customers within their assigned territory for Kollmorgen branded products. The ASM will assume some established customers and be responsible developing opportunities ...
-
Machinist - 2nd Shift
8 hours ago
Regal Rexnord Radford, United StatesPosition Summary: The Machinist is responsible for operating machine tools to produce precision metal parts. This position is part of the Kollmorgen team in Radford, VA. Kollmorgen is part of Altra.Essential Duties and Responsibilities:To perform this job successfully, an individ ...
NPI Quality Engineer III - Salem, United States - Integer Holdings Corporation
Description
By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.
At Integer, our values are embedded in everything we do.
Customer
We focus on our customers' success
Innovation
We create better solutions
Collaboration
We create success together
Inclusion
We always interact with others respectfully
Candor
We are open and honest with one another
Integrity
We do the right things and do things right
The 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. Provide work direction for 3-5 Technicians/Inspectors.
Key Accountabilities and Responsibilities
Job Requirements
Minimum Education:
Bachelor's Degree in Engineering or related field required.
Minimum Experience:
5-7 years' experience in medical device or regulated manufacturing
Specialized Knowledge:
Competence in the selection and use of Quality Engineering Tools and Techniques.
Good knowledge in the interpretation and application of relevant Domestic and
International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.)
Proficient in Microsoft Office and Minitab Special Skills:
Knowledge of SPC, FMEA, DOE, RCA, GDT
Sound knowledge of quality management systems.
Other:
Certified Quality Engineering (CQE), Certified Software Quality Engineer (CSQE), Certified Reliability Engineer (CRE), Certified Quality Auditor (CQA), Certified Bi
Ability to work independently and in team environment.
Ability to effectively communicate written and verbally.
Ability to manage time effectively to ensure timely completion of tasks.
omedical Auditor (CBA), or Six Sigma Green Belt or Black Belt desired.
U.S. Applicants: EOE/AA Disability/Veteran