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Mack Moldingis recognized as one of the worlds premier custom manufacturers of high quality complex parts, assemblies, and total products in plastic and metal.We have been in business since 1920, and have grown to over 2000 employees in seven plants located throughout the eastern United States.

Mack Moldingoffers a variety of services throughout its numerous facilities,resulting in many diverse career paths and advancement opportunities. And when new opportunities arise, whether on the manufacturing floor, out in the field, or in the corporate offices, Mack strives to promote its talent from within.

Essential 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 standards and 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 (DVQRs) 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 CCRs 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 QBRs 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

Working knowledge of Statistical techniques & sampling plans and of Quality Systems Regulations. Bachelors degree (B.A.) in technical field desired, plus 2 years related experience preferred. Experience in medical device-manufacturing environment, and experience with Six Sigma or Lean are preferred.

To view all Mack job postings and to apply visit:

Mack Molding CO INC

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