Quality Engineer - Medical Devices

Mack Molding CO INC • Arlington, VT • 1w ago

This job was posted by https://www.vermontjoblink.com : For more information, please see: https://www.vermontjoblink.com/jobs/1326111

Provides quality engineering support during new business development, program launches, and for existing customers. The Quality Engineer will ensure that manufacturing processes, quality systems, and finished products for medical devices meet all applicable regulatory, customer, and internal quality requirements.

This role involves working in anITAR-controlled environment. The

successful candidate will have a strong technical background, problem-solving skills, and the ability to work within the strict compliance requirements of ITAR regulations.

Essential Duties and Responsibilities:

Support new business development

Provides support to new business development relating to quality

matters as needed.

Draft preliminary Quality Plan, if appropriate.

Provides cost and time estimates for anticipated quality

department services such as metrology or validation services.

Functions as a resource for CFR Part 820 and ISO 13485

regulatory requirements.

**Support Program Launch and Product Realization as functional

department representative assigned to team and Program Manager**
Reviews new program drawings/information/customer specifications

to understand program requirements.

Support customer audits, regulatory inspections, and

certification.

Drafts program Quality Plan, PFMEA, and Dynamic Control Plans as

required.

Drafts other required quality documentation such as Dimensional

Visual Quality Requirements (DVQRs) and new product inspection techniques.

Confirms customer agreement on GD&T callouts/interpretations and

all critical dimensions of program when required.

Prepares manufacturing job travelers and associated process

documents.

Develops required Control/Test methods.

Ensures First Article Inspection (FAI) and Capability Studies

are scheduled and completed.

Completes FAI and capability study analysis for submission to

customer.

Generates validation plans, operational qualification (OQ),

performance qualification (PQ) protocols, and provides training for protocol participants.

Oversees the execution of assigned validation activities to

ensure compliance with protocol requirements and completion of study tasks.

Generates Required validation completion reports to include

resolution of any deviations recorded and overall study conclusion.

Perform first-piece and in-process approvals for new setups,

tooling changes, or process adjustments.

Attends program team meetings to support production-related

matters.

Performs assigned activities in a timely manner.

**Provide continuous quality engineering support through program end

of life.**
Completes Certificates of Conformance (CoC) for outgoing

products, where required.

Collects and analyzes production line data to monitor yield and

defect performance.

Use statistical tools (SPC, DOE, capability studies) to identify

process improvement opportunities.

Maintains Device Master Records including Device History Records

as required.

Performs periodic risk assessments, as required.

Assists Purchasing Department with maintaining vendor quality

requirements.

Continuously monitors production to identify quality-related

customer issues and supports corrective action plans when necessary.

Issue or authorize customer complaints and returns as needed.

Manages the return of goods, assignments and close out of RC/CA.

Documents nonconformances, conducts thorough root cause

analyses, and develops and implements effective corrective action plans.

Manages product and process change control and notification to

ensure required Engineering Change Orders (ECOs) are generated and approved by the customer prior to implementation.

Attends program team meetings as necessary to resolve program

quality issues to maintain customer satisfaction.

Support quality business reviews with customer and

provides/presents quality-related topics.

Participates in customer, certified body, and regulatory audits

as a subject matter expert for assigned products and processes.

Has a working knowledge of:

Statistical techniques and tools (Minitab) and sampling plans.

**Strong analytical and root cause problem-solving skills (5-Whys,

Fishbone, 8D).

**Quality Systems Regulations and ISO Standards.

Advanced Product Quality Planning (APQP)

**Multiple manufacturing processes (e.g., injection molding,

machining, assembly, packaging).

**Occasional domestic travel required.

Other duties as assigned.

Competency:

To perform the job successfully, an individua

Similar Jobs

Patient Coordinator (PC)- Pediatrics

Dartmouth Health • Bennington, VT • 1d ago

Hospital & Medical

The Patient Coordinator is responsible for providing reception, administrative and clerical support to the Putnam Medical Practice Pediatric office. Ability to work in a fast-paced, multi-tasking clinical environment. Ab...

1d ago

Go to Apply

Patient Coordinator (PC)-Gastroenterology

Dartmouth Health • Bennington, VT • 1d ago

Hospital & Medical

Performs receptionist duties, including, but not limited to, meet and greet of walk-in and telephone patients/families Performs patient in-take, including, but not limited to, collecting and/or confirm patient demographi...

1d ago

Go to Apply

Medical Technologist

Dartmouth Health • Bennington, VT • 1d ago

Hospital & Medical

The Medical Technologist is responsible for performing analytical testing, quality control, and providing technical expertise in any one or all of the lab areas. Bachelor's Degree in Medical Technology or related health...

1d ago

Go to Apply

Instrumentation & Controls Technician - Manufacturing - Tape Solutions

Saint-Gobain • Hoosick Falls, NY • 4d ago

Hospital & Medical

If you want to reshape the world and discover your greatest potential, Saint-Gobain provides one-of-a-kind opportunities for innovative problem solvers. We're one of only two companies in the world that is consistently r...

4d ago

Go to Apply

Pharmacy Customer Service Associate

Walgreens • Bennington, VT • 1w ago

Hospital & Medical

Job Description: Models and delivers a distinctive and delightful customer experience. Registers sales on assigned cash register, provides customers with courteous, fair, friendly, and efficient checkout service. In acco...

1w ago

Go to Apply

APRN, Neurology

Dartmouth Health • Bennington, VT • 1w ago

Hospital & Medical

Overview Southwestern Vermont Medical Center (SVMC) is seeking a Nurse Practitioner or Physician Assistant to join a team of experienced and dedicated Neurology professionals. Engaged provider team who are invested in te...

1w ago

Go to Apply

Nurse Manager

UNITED COUNSELING SERVICE • Bennington, VT • 2w ago

Hospital & Medical

This job was posted by https://www.vermontjoblink.com : For more information, please see: https://www.vermontjoblink.com/jobs/1324907 Why join UCS? Since 1958, United Counseling Service (UCS) has been dedicated to provid...

2w ago

Go to Apply

Imaging Scheduler, Central Wide Scheduling

Dartmouth Health • Bennington, VT • 2w ago

Hospital & Medical

The Scheduler works with referring provider offices to schedule patient imaging testing such as mammograms, x-rays, ultrasounds, cat scans, MRI's, ext. They will also work with insurance companies to obtain prior authori...

2w ago

Go to Apply

Physical Therapist, Home Health

BAYADA Home Health Care • Bennington, VT • 2w ago

Hospital & Medical

**Bonus Available for full time only Be the Physical Therapist you always wanted to be at BAYADA Home Health! Work with clients in their home, craft treatment plans, and apply innovative techniques to help them reach the...

2w ago

Go to Apply

Administrative Coordinator (AC)- Internal Medicine

Dartmouth Health • Bennington, VT • 3w ago

Hospital & Medical

The Administrative Coordinator Responsibilities Include: Assists in the coordination of the development, implementation and evaluation of department patient care standards and practice. Coordinates and leads a variety of...

3w ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.