1st Shift Mold Operator

Job Description

Summary/objective

Operates department machine and equipment according to Standard Operating Procedures (SOPs), Machine Setup (MS), Manufacturing Procedure (MP) instructions, job orders, specifications, engineering drawings, and job order special instructions. Maintains quality system requirements for medical device manufacturer according to ISO 13485 and FDA 21 CFR 820.

Essential functions

• Adheres to Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDP).

• Reads work order and/or engineering drawings and manufacturing specifications to produce product as required.

• Communicates with co-workers and supervisors to receive instructions and coordinate activities along with job order performance.

• Visually inspects or measures in-process and finished product for specified quality attributes.

• Completes work orders and other related Device History Record (DHR) paperwork as required.

• Supports 55, Lean Six Sigma, and continuous improvement projects within the department and facility to support quality objectives, along with customer and business needs.

• Other duties may be assigned

Competencies

• Great Attention to detail

• Must speak/read/write English.

• Must be organized, have initiative, and ability to work well and cooperate with all levels of the department.

Supervisory responsibilities

• N/A

Required education and experience

• Minimum High School Diploma or GED.

• One (1) to three (3) years related experience and/or training or equivalent combination of education and experience.

• Must be familiar with Good Manufacturing Practices (GMP)/Quality System Regulations (QSR)/Good Documentation Practices (GDP).

Preferred Education and experience

• Previous experience in the medical device industry

Job Description

Summary/objective

Operates department machine and equipment according to Standard Operating Procedures (SOPs), Machine Setup (MS), Manufacturing Procedure (MP) instructions, job orders, specifications, engineering drawings, and job order special instructions. Maintains quality system requirements for medical device manufacturer according to ISO 13485 and FDA 21 CFR 820.

Essential functions

• Adheres to Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDP).

• Reads work order and/or engineering drawings and manufacturing specifications to produce product as required.

• Communicates with co-workers and supervisors to receive instructions and coordinate activities along with job order performance.

• Visually inspects or measures in-process and finished product for specified quality attributes.

• Completes work orders and other related Device History Record (DHR) paperwork as required.

• Supports 55, Lean Six Sigma, and continuous improvement projects within the department and facility to support quality objectives, along with customer and business needs.

• Other duties may be assigned

Competencies

• Great Attention to detail

• Must speak/read/write English.

• Must be organized, have initiative, and ability to work well and cooperate with all levels of the department.

Supervisory responsibilities

• N/A

Required education and experience

• Minimum High School Diploma or GED.

• One (1) to three (3) years related experience and/or training or equivalent combination of education and experience.

• Must be familiar with Good Manufacturing Practices (GMP)/Quality System Regulations (QSR)/Good Documentation Practices (GDP).

Preferred Education and experience

• Previous experience in the medical device industry

Pay Details: $17.50 to $20.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act

• Los Angeles City Fair Chance Ordinance

• Los Angeles County Fair Chance Ordinance for Employers

• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.