- Working knowledge ISO 13485:2016 and FDA requirements (21 CFR 820), and other equivalent applicable standards.
- Prior experience within electronic Quality Management Systems (eQMS) such as CEBOS, Green Light Guru, Master Control, Qualio, Veeva, or similar applications and systems.
- Highly proficient in the use of Microsoft Office including Outlook, Word, Excel, Power Point, Project, Visio, SharePoint, Teams, and Adobe Acrobat Pro.
- Previous familiarity with Minitab or other Statistical Programs.
- Team player with strong matrix team leadership and participatory / collaborative skills
- BS Degree in a technical field: plastics, mechanical, chemical, or biomedical engineering field and at least 5 years of relevant experience OR the equivalent combination of education.
- 5-year minimum experience from a medical device company, or similarly regulated environment.
- Supplier Quality Engineer experience with 5 years from a medical device or Pharma company.
- ASQ Certifications as a Quality Engineer and/or Quality Auditor. Training methods experience is also preferred.
- Functional Knowledge of Quality KPI & SPC.
- Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
- Investigates customer complaints, performs return sample evaluations, root cause analysis, and implements changes to the quality system where needed based upon investigations, supporting the CF coordinator by preparing and communicating the final reports to the customer.
- Evaluates verification and validation protocols and reports to ensure compliance to external standards and internal standards and procedures.
- Provides expertise in risk management and analysis techniques when facilitating completion of pFMEA/FMEA within a cross functional team.
- Evaluates risk during reviews of NCs.
- Responsible for and facilitates the development and implementation of quality engineer metrics as KPIs (Key Performance Indicators).
- a. Implements effective measurement and analysis of the QMS, procedures and methods. Shall recommend improvements.
- Reviews and approves controlled documents (e.g., SOPs, specifications, methods, change control, protocols, reports, investigations, deviations, CAPAs, source documentation, etc.) to ensure defined quality objectives are met.
- Tracks reoccurring quality and compliance-related commitments and activities as related to Supplier Quality.
- Participates in audits, customer meetings, site visits and inspections, working closely with peers in the organization.
- Supports the internal audits within the organization and tracks compliance of corporate QMS to applicable standards.
- Ensure, respect and follow workplace safety rules including, but not limited to, proper PPE, proper handling practices of chemicals per procedures, maintaining safe work practices, follow LOTO and HAZMAT polices, refer to SDS when applicable, and apply information found to the task at hand.
- Generally, working in an office environment and on a manufacturing floor, 50/50.
- Travel could be required.
- Requires data entry and regular use of
- Regularly required to stand, sit, walk, use hands to input, able to hear and talk.
-
Quality Engineer
1 week ago
Aurora Ventures Warwick, United StatesYour Responsibilities · Manage suppliers specializing in non-corrosive and tool steels · Execute and monitor qualification and supplier approval processes · Collaborate with the product development team · Review and create specifications and quality-related documents · Your Profi ...
-
Quality Engineer
4 days ago
Kelly Science, Engineering, Technology & Telecom Westborough, United StatesHello, my name is Daniel, and I am a recruiter with Kelly Services. One of our prominent clients is seeking a Quality Engineer in Westborough, MA. · Responsibilities: · Provide manufacturing and/or engineering process support in accordance with documented procedures and practices ...
-
Quality Engineer
2 weeks ago
Telephonics Stafford Springs, United StatesPerform product assurance activities of a complex nature to assure that the dimensional, material, and visual characteristics of the products design, as documented on drawing, specifications, and quality standards, consistently meet the customers t Quality Engineer, Process Engin ...
-
Quality Engineer
3 days ago
Kelly Science, Engineering, Technology & Telecom Westborough, United StatesHello, my name is Daniel, and I am a recruiter with Kelly Services. One of our prominent clients is seeking a Quality Engineer in Westborough, MA. · Responsibilities: · Provide manufacturing and/or engineering process support in accordance with documented procedures and practic ...
-
Quality Engineer
5 days ago
Mativ Barrington, United States· We have a great Quality Engineer opportunity in our Great Barrington, MA location. · This position is responsible for the quality of the laminated product produced on the Great Barrington Laminator, reporting the necessary quality metrics, leading quality complaint investigat ...
-
Quality Engineer
1 week ago
Eaton East Providence, United StatesEaton's Aerospace Division is currently seeking a Quality Engineer to join our team. This position is based at our Rumford, Rhode Island facility. · The expected annual salary range for this role is $ $ a year. This position is also eligible for a variable incentive program. · Pl ...
-
Quality Engineer
3 days ago
Kelly Services, Inc. Westborough, United States#x 9; Provide manufacturing and/or engineering process support in accordance with documented procedures and practices. Responsible for the development, implementation, improvement, and continuous reinforcement of established Quality Assurance fundame Quality Engineer, Engineer, Q ...
-
Quality Engineer
1 week ago
TTM Technologies Stafford Springs, United StatesTTM Technologies, Inc. – Publicly Traded US Company, NASDAQ (TTMI) – Top-5 Global Printed Circuit Board Manufacturer · About TTM · TTM Technologies, Inc. is a leading global manufacturer of technology solutions including engineered systems, radio frequency ("RF") components and ...
-
Quality Engineer
1 week ago
The Griffin Groupe Millbury, United StatesCompany · : · Client of The Griffin Groupe Executive Search · Job Type · : · Full Time · Location · : · Millbury, MA · Industry · : · Manufacturing · Rate · : $ · 125K · Relocation: · Available to Qualified Candidates · QUALITY ENGINEER · JOB DESCRIPTION · This Q ...
-
Quality Engineer
1 week ago
Plansee Group Franklin, United StatesResponsible for the overall compliance with regards to the AS9100 certification. This position will maintain and improve manufacturing capabilities and efficiencies by determining opportunities for improvement. This includes the administration of standard operating procedures (SO ...
-
Quality Engineer
1 week ago
BARRDAY CORP Millbury, United StatesJob Description · Job DescriptionBarrday, a manufacturer of composite materials, is in search of a Quality Engineer. · ABOUT US: · Barrday is a leading advanced materials solutions company with an international manufacturing and sales presence. Our product lines encompass applica ...
-
Quality Engineer
5 days ago
Mativ Barrington, United States· We have a great Quality Engineer opportunity in our Great Barrington, MA location. · This position is responsible for the quality of the laminated product produced on the Great Barrington Laminator, reporting the necessary quality metrics, leading quality complaint investigat ...
-
Quality Engineer
1 week ago
Barrday Millbury, United StatesBarrday, a manufacturer of composite materials, is in search of a Quality Engineer. · ABOUT US: · Barrday is a leading advanced materials solutions company with an international manufacturing and sales presence. Our product lines encompass applications for the composite and prote ...
-
Quality Engineer
1 week ago
TTM Technologies Stafford Springs, United StatesTTM Technologies, Inc. - Publicly Traded US Company, NASDAQ (TTMI) - Top-5 Global Printed Circuit Board Manufacturer · About TTM · TTM Technologies, Inc. is a leading global manufacturer of technology solutions including engineered systems, radio frequency ("RF") components and R ...
-
Quality Engineer
4 days ago
Search Staffing Group Inc. Franklin, United StatesJob Description · Job DescriptionSalary: $80,000 - $95,000 · Quality Engineer · Direct hire position with full company benefits. · Entry level graduates with Co-Op, Internship experience encouraged to apply · Candidates will have experience in the following. · Develop, maintain, ...
-
Quality Engineer
1 week ago
Synectics Worcester, United StatesJob DescriptionJob Description · Description: · Responsible for commissioning and qualification activities associated with capital projects involving the installation and/or renovation of biopharmaceutical process equipment, facilities, and utilities in an FDA/GMP regulated env ...
-
Commercial Clerk
2 weeks ago
Emerald Enterprises Dayville, CT, United States FreelanceJoin the Logwin team We are looking for a Commercial Clerk (m/f/d) at our location in Reichshof, Dayville, CT. · **Do you want to make a difference? Shape the future with a leading logistics service provider - and be personally valued and supported?** · With 4,100 employees at ov ...
-
Manufacturing Quality Engineer
5 days ago
Kelly Science, Engineering, Technology & Telecom Westborough, United StatesManufacturing Quality Engineer · Location: Onsite - Westborough, Massachusetts · Type: Contract - (NO C2C OR THIRD PARTY) · Pay Rate – Negotiable depending on DIRECT-related experience · Work Authorization - Must be able to work in the U.S. with approved authorization status as ...
-
Supplier Quality Engineer
1 day ago
Nordson East Providence, United StatesCollaboration drives Nordson's success as a market leader in Industrial Precision Solutions and Advanced Technology. Our employees thrive in an environment where we help each other reach our personal best and enable our company to continuously improve and grow, and our customers ...
-
Sr Quality Engineer
5 days ago
Precision Castparts Corp Worcester, United StatesCountry · United States of America · State / County · Massachusetts · City · Worcester · Division · Wyman Gordon · Company · Worcester · Function · Quality · Workplace Type · On-Site · Position type · Full Time · Opportunity ID · 13125 · Company Profile · With ...
Quality Engineer - East Killingly, United States - Job Juncture
Description
Job DescriptionThe Quality Engineer supports our client by working in support of production, supplier quality, and development programs.
The successful candidate is responsible for developing and maintaining quality standards, plans, and procedures to assure our products and processes meet required specifications, regulatory standards, and system requirements.
The successful candidate will demonstrate a dedication to both company and departmental continuous improvement as a requirement.The QE works harmoniously and participates in cross functional team / collaboration activities to deliver highly spec compliant product results.
In addition to the Required Qualifications for the role other Essential Duties and Responsibilities includes but is not limited to competency in administering QMS, Audits, Safety and other duties as assigned.
Required Qualifications:
·
Bachelor's degree in engineering or science, or equivalent work experience.
·
A minimum of two (2) years related to manufacturing experience in a QMS environment.
Preferred Qualifications:
QMS:
Audits:
Safety:
Physical Requirements:
for extended periods of time.
