Quality Engineer-Cavendish

Location: Cavendish

Mack is a leading contract manufacturer, with a dynamic environment for manufacturing components and finished products needed in our every day world. Robotics, 3D printers, mail automation equipment, air cleaning devices, as well as high-end furniture. Exciting products - exciting people! Come join our team! Mack seeks an Engineer to provide quality engineering support during new business development, new program launches and for existing customer programs

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 applicable ISO Program and QSR Program 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

* Determines quality and reliability standard sand ensures dimensional and cosmetic requirements, as well as customer specifications, are defined and understood.

* Drafts program Quality Plan (as required) and metrology labor plan to include definition of required fixtures, calibration and metrology requirements and measurement methods needed to meet customer requirements for approval

* Drafts other required quality documentation such as Dimensional Visual Quality Requirements (DVQR's) and new product inspection techniques

* Confirms customer agreement on GD&T callouts/interpretations and all critical dimensions of program when required

* Prepares Failure Mode Effects Analysis (FMEA), as needed

* Prepares Traveler Document

* 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

* Authors operational qualification (OQ) and performance qualification (PQ) protocols and provides training for protocol participants

* Oversees the execution of assigned OQ and PQ studies to ensure compliance with protocol requirements and completion of study tasks

* Authors OQ and PQ Completion Reports to include resolution of any deviations recorded and overall study conclusion

* Establishes "golden sample" standards and prepares and submits to customer via customer approval form (CAF) as required

* Attends program team meetings to address quality-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

* Ensures golden samples are retained and controlled

* Maintains Device History Records (DHR) as necessary

* 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 CCR's as needed. Manages the return of goods, assignments and close out of RC/CA.

* Conducts root cause investigation and develops corrective action plans for assigned problem reports (PSRs) and quality issues

* 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 Q 's 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

* Occasional domestic travel required

* Has a working knowledge of Statistical techniques and sampling plans and of Quality Systems Regulations and ISO Standards

* Other duties as assigned

Competency:

To perform the job successfully, an individual should demonstrate the following competencies:

Analytical - Collects and researches data;
Uses intuition and experience to complement data.

Problem Solving - Identifies and resolves problems in a timely manner;
Gathers and analyzes information skillfully;
Develops alternative solutions.

Customer Service - Manages difficult or emotional customer situations;
Responds promptly to customer needs;
Responds to requests for service and assistance;
Meets commitments.

Interpersonal - Listens to others without interrupting;
Remains open to others' ideas and tries new things. Behaves in a respectful and professional manner.

Oral Communication - Speaks clearly and persuasively in positive or negative situations;
Listens and gets clarification;
Responds well to questions.

Written Communication -…