Quality Engineer - Wilmington, United States - Spectra Medical Devices

Spectra Medical Devices Wilmington, United States

6 days ago

Description

Job DescriptionJob Description

POSITION SUMMARY:
The desired candidate will have prior experience working as a Quality Engineer, preferably working in a medical device company.

Specific experience and responsibilities will include, but not limited to, providing Quality and Compliance related support to the manufacture and distribution of medical devices in accordance with applicable medical standards and regulations (ISO 13485, 21 CFR 820, etc.).

.

ESSENTIAL FUNCTIONS /

MAJOR RESPONSIBILITIES:
Provide technical support for review and approval of customer complaint investigations

Facilitate Non conformances and MRB activities

Facilitate the execution of Risk Management activities

Identify statistically-based sampling plans for inspections and validations

Support validations for new and existing products, processes and equipment

Ensure compliance with cGMP, QSR, ISO13485, MDD, and other applicable

regulations/standards

Participate in FDA inspections, ISO Registration and surveillance audits and customer audits

Identify and implement opportunities for continuous improvement

Interact and coordinate activities with other departments, external vendors and customers

Assist or lead in the identification and implementation of CAPA

Aid in the implementation SPC control system with Manufacturing and Quality Control

Support internal quality system audits

Provide support necessary for supplier controls, including but not limited to: supplier audits

Participate in Post-Market Surveillance (PMS) activities as required

Collect and report metrics and data as required

Perform other Quality System related duties as required

DESIRED SKILLSET:
Minimum of Bachelors degree, preferably in Engineering, Science (Biology, Chemistry, Physics, etc.) or Math (Statistics)

Certified Quality Auditor (ASQ CQA) or Certified Quality Engineer (ASQ CQE) would be a plus

3+ yrs Quality Engineering experience in a manufacturing or industrial environment, preferably in an FDA regulated environment

Knowledge of statistical sampling and analysis

Knowledge of ISO, FDA, and QSR concepts and guidelines as well as other national and international regulations and standards

Ability to read blueprints and interpret Geometric Dimensioning and Tolerances (GD&T)

Experience performing quality audits and utilizing manufacturing processes, techniques, and continuous improvement methodologies (i.e, Six Sigma, Lean manufacturing, etc.).

Excellent organizational, verbal, written communication and problem solving skills

Possess above-average interpersonal skills demonstrating the ability to work with others in a professional, positive and collaborative manner

Ability to work in a fast-paced environment and to meet tight deadlines

Willingness to learn, possess a can do attitude, and motivated to succeed and grow

Ability to problem solve, and multi-task with strong attention to detail

Proficient in MS Office Suite, Visio and Project

Experience working in a start-up environment, helpful

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, grip, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk and hear.

The employee must occasionally lift and /or move up to 40 pounds.

Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

ADA Statement:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

At-Will Employment:

I acknowledge that my employment with the Company is on an at will basis which means that either I or the Company can end the employment relationship at any time, for any reason, with or without prior notice.

An Equal Opportunity Employer:
Spectra believes that all persons are entitled to equal employment opportunity.

The Company will not discriminate or tolerate discrimination against any employee or applicant because of race, color, creed, religion, genetic information, sex, sexual orientation, national origin, age, status with regard to public assistance, marital or veteran status, disability or any other characteristic protected by local, state or federal law.

Equal employment opportunity will be extended to all persons in all aspects of the employer-employee relationship, including recruitment, hiring, training, promotion, transfer, discipline, layoff, recall and termination.

Disabled applicants may request any reasonable accommodation needed to enable them to complete the application process.

#J-18808-Ljbffr

Quality Engineer

1 week ago

Jonathan Edward Staffing Wilmington, United States

Sr. Quality Engineer · 143-166k · Hybrid in Wilmington, MA · This position requires demonstrated technical proficiency in implementing automation solutions with PLC, DCS, HMI, and SCADA platforms. You will interact directly with the customer and lead a team in identifying requ ...
Site Quality Engineering Manager

6 days ago

Lockheed Martin Corporation Andover, United States

**JOB ID**: 665892BR · **Date posted**: May. 09, 2024 · **Description**: · Lockheed Martin is seeking an experienced, highly motivated Quality Engineering Manager to lead the Quality Assurance organization at Lockheed Martin's cutting-edge Energy operations based in Andover, Mass ...
Site Quality Engineering Manager

6 days ago

Lockheed Martin Andover, United States

**Job ID**: 665892BR · **Date posted**: May. 09, 2024 · **Description**:Lockheed Martin is seeking an experienced, highly motivated Quality Engineering Manager to lead the Quality Assurance organization at Lockheed Martin's cutting-edge Energy operations based in Andover, Massach ...
Quality Engineer

1 week ago

Velocity Solutions North Walpole, United States

About the Company · As a system partner of the office furniture industry, we specialize in the development and production of functional fittings made of metal and plastic. As one of the leading companies in Europe, we strive to quickly and flexibly fulfill individual customer req ...
Quality Engineer

6 days ago

Precision Life Sciences Burlington, United States

Job Description: Quality Engineer · The Quality Engineer will support sustaining engineering and new product development activity for the Quality Assurance department in a dynamic and complex engineering environment. · RESPONSIBILITIES · Support sustaining engineering through ope ...
Quality Engineer

6 days ago

Astrix Technology Burlington, United States

Quality Engineer · Quality Assurance · Burlington, MA, US · Pay Rate Low: 35 | Pay Rate High: 44 · + Added - 01/04/2024 · Apply for Job · **Job Description:** · + Support manufacturing processes for medical implant and medical external cable assemblies, with a primary focu ...
Senior Quality Engineer

6 days ago

Katalyst Healthcares and Life Sciences Wilmington, United States

Responsibilities:Support validations for new and existing products, processes and equipment. · Manage NC/CAPA teams through identification and development of corrective action plans, verification and closure. · Coordinate and support supplier quality management activities, includ ...
Senior Quality Engineer

13 hours ago

restor3d Wilmington, United States

Job Description · Job DescriptionJob Summary: · The Senior Quality Engineer will be responsible for assisting in the development, implementation, and maintenance of the quality system of the company including supporting all FDA and registrar inspections/audits. · Essential Duties ...
Product Quality Engineering

6 days ago

Analog Devices Wilmington, United States

Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized facto ...
Quality Engineer

4 days ago

Servomex Woburn, United States

Servomex, the world leader in gas analysis, is looking to expand our Quality Team. This is an exciting opportunity for a Quality Engineer to join our high performing team at our site in Woburn, MA. · The successful candidate will work closely with our manufacturing teams at our U ...
Quality Engineer

6 days ago

Servomex Woburn, United States

Servomex, the world leader in gas analysis, is looking to expand our Quality Team. This is an exciting opportunity for a Quality Engineer to join our high performing team at our site in Woburn, MA. · The successful candidate will work closely with our manufacturing teams at our ...
Quality Engineer

6 days ago

SolidEnergy Systems Woburn, United States

Quality Engineer · About Us · SES is a global leader in development and production of high-performance Li-Metal rechargeable batteries for electric vehicles (EVs) and other applications. Founded in 2012, SES is an integrated Li-Metal battery manufacturer with strong capabilitie ...
Quality Engineer

6 days ago

Motion Recruitment Partners LLC Woburn, United States

Our client is a leading innovator in the medical device industry, dedicated to improving healthcare outcomes through cutting-edge technologies. They are seeking a highly skilled and motivated Quality Engineer specializing in Design Assurance to join their dynamic team. As a Quali ...
Quality Engineer

6 days ago

EHR SERVICES LLC Woburn, United States

Covaris, LLC. ) is a profitable technology company headquartered in Woburn, Massachusetts, USA. Covaris has developed a proprietary and patented Adaptive Focused Acoustics (AFA) technology platform, which is utilized in sample preparation processes in the analytical and life scie ...
Quality Engineer

4 days ago

Randstad USA Billerica, United States

Job Summary · Our client north of Boston is looking for a Quality Engineer to join their growing team This is a great opportunity for someone who is looking for a team oriented environment. Our client is very focused on working together to complete projects using cross collaborat ...
Quality Engineer

4 days ago

EHR Services Woburn, United States

Job Description · Job DescriptionCovaris, LLC. ) is a profitable technology company headquartered in Woburn, Massachusetts, USA. Covaris has developed a proprietary and patented Adaptive Focused AcousticsTM (AFA) technology platform, which is utilized in sample preparation proces ...
Quality Engineer

1 week ago

Randstad USA North Billerica, United States Full time

job summary: · Our client north of Boston is looking for a Quality Engineer to join their growing team This is a great opportunity for someone who is looking for a team oriented environment. Our client is very focused on working together to complete projects using cross collabora ...
Quality Engineer

2 days ago

Randstad Billerica, United States

Job Summary · Our client north of Boston is looking for a Quality Engineer to join their growing team This is a great opportunity for someone who is looking for a team oriented environment. Our client is very focused on working together to complete projects using cross collabora ...
Senior Quality Engineer

6 days ago

Imaginary Burlington, United States

Position Introduction: · 10Beauty is seeking a Senior Quality Engineer who will play a crucial role in owning and ensuring the highest standards of quality throughout our organization. This position requires a strategic thinker with a deep understanding of change control process ...
Engineer, Software Quality

1 week ago

The Fountain Group Burlington, United States

This is an onsite role, remote work not possible. · Pay $50-53/hour W2. · W2 Candidates only for this role, C2C not possible. · DescriptionThis position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for ...