Manufacturing Operator / Medical Device Assembler

Job Description

Job Description

Shift: Mon - Fri, 5:30 am to 2:00 pm

Job Description:

Our manufacturing company is seeking a team member to join our Reagent Pack Value Stream team.

In this role, you will formulate, fill, test, and package chemical and biological reagent products of varied complexity according to operational plans and customer demand.

We’re looking for associates who thrive in a team-oriented, goal-focused environment.

We operate using Daily Management principles, providing immediate guidance and feedback to our associates and focusing on daily, monthly, and quarterly objectives.

You’ll be responsible for following established operational procedures, maintaining appropriate training records for your role, sustaining a smooth flow of material and ensuring the execution of work orders to on-time completion.

We are a growing organization looking for associates who meet the qualifications below.

Our work delivers both instruments and reagents to customers in hospital and laboratory environments, supporting patient health.

We look forward to speaking with you & working to further your career.

Key Responsibilities:

Read, comprehend and follow established work instructions and procedures with emphasis on quality.

Execute the daily production plan to due date conformance and quality standards.

Train on Standard Operating Procedures (SOPs).

Follow engineering drawings, work order information, SOPs, and other written and verbal specifications in the manufacturing process while maintaining FDA requirements.

Independently execute work regarding formulating, filling, testing and packaging.

Apply basic analytical skills or scientific methods to perform daily tasks.

Perform the set-up, calibration, testing and troubleshooting of reagent components and instruments.

Conduct testing on solutions that include pH, conductivity, and density to ensure adherence to production/process specifications.

Assure compliance with FDA Quality System Regulations (QSR), Good Manufacturing Practices (GMP), and ISO regulatory requirements.

Work directly and cooperatively with cross-functional team members to troubleshoot issues and ensure emphasis on quality.

Identify, recommend and implement quality improvements, including but not limited to production methods, equipment performance, product quality and efficiencies.

Learn and participate in the company's lean manufacturing principles.

Maintain a safe and clean working environment by complying with procedures, rules, and regulations.

Perform other duties and cross-training as assigned.

Train new team members on equipment operations and work procedures as needed.

Ability to complete appropriate paperwork, maintain accurate records of production and report the status of work.

Must read, write and speak fluent English. Proficiency with Microsoft applications.

Our Leadership Competencies:

We value associates with solid decision-making and priority-setting skills, and who are going to thrive in a diverse environment where individual contribution and team effort are equally important.

Physical Demands:

While performing the duties of this job, the associate is regularly required to stand for prolonged periods of time.

The employee is frequently required to talk and hear; use hands to handle or feel; and reach with hands and arms above shoulder height and below the waist.

The associate must be able to read and speak English.

Using proper lifting techniques, the employee must be able to lift up to 30 lbs.

The associate must have good hand dexterity.

Ability to maneuver assembly components by hand in a repetitive manner conducive to efficiency, job specifications, safety, and quality goals.

Ability to frequently stand (80%), bend, kneel, lift and sit to accomplish assembly production goals.

Education/Experience:

Must have 2+ years of relevant experience.

Experience in a regulated industry preferred (e.g. FDA, ISO).

Select Source International (SSI) is a distinguished workforce solutions provider with nearly 25 years of experience delivering top-tier staffing, recruiting, and managed services. Based in Minneapolis, Minnesota, SSI has established itself as a global leader, serving a broad, diverse clientele across industries with unwavering dedication and excellence.

As a trusted partner, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your evolving workforce needs. SSI is ISO 9001, ISO 14001, and SOC 2 Type II certified, underscoring our strict commitment to quality, environmental responsibility, and data security. Our industry-leading capabilities are further validated by numerous awards in sustainability and supplier diversity.

Company Description

Select Source International (SSI) is a distinguished workforce solutions provider with nearly 25 years of experience delivering top-tier staffing, recruiting, and managed services. Based in Minneapolis, Minnesota, SSI has established itself as a global leader, serving a broad, diverse clientele across industries with unwavering dedication and excellence.\r\n\r\nAs a trusted partner, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your evolving workforce needs. SSI is ISO 9001, ISO 14001, and SOC 2 Type II certified, underscoring our strict commitment to quality, environmental responsibility, and data security. Our industry-leading capabilities are further validated by numerous awards in sustainability and supplier diversity.