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Rockline Industries, people who make it right · 3 days ago

Quality Engineer II

Morristown, TN

Full-time

Onsite

Mid Level

3+ years exp

Rockline Industries is a company that produces FDA-regulated wet wipes in controlled manufacturing environments. As a Quality Engineer II, you will develop validation protocols, collaborate with customers on validations, and drive continuous improvement initiatives to ensure product safety and compliance.

ConsumerConsumer GoodsHealth CareManufacturing

H1B Sponsor Likely

Responsibilities

Develop and execute validation protocols (IQ/OQ/PQ) for equipment, sanitation, facilities, software, and processes

Collaborate with customers on equipment and process validations

Serve as the database administrator for Infinity QS (Statistical Process Control) software

Provide statistical analysis support for manufacturing, new product development, trials, and validations

Develop SOPs related to validation and risk management

Monitor and prepare Key Performance Indicators (KPIs) for major customers

Lead Corrective Action/Preventative Action (CAPA) activities and facilitate root cause investigations

Train associates on quality topics such as SPC and CAPA

Drive continuous improvement initiatives with internal teams and external partners

Qualification

Validation protocolsStatistical Process ControlRoot cause analysisFDA regulationsSOP developmentContinuous improvementProblem-solvingCollaboration

Required

Bachelor's degree in Engineering, Science, or related field

3+ years of engineering experience, preferably in manufacturing

Background in nutritional products, medical devices, pharmaceuticals, or similar industries

Experience in FDA-regulated environments

Experience with validations

Strong problem-solving and root cause analysis capabilities

Ability to work independently and collaboratively in a fast-paced setting

Flexible schedule to support production and validation activities

Benefits

Medical, dental, vision coverage, wellness programs, and fitness reimbursement

Retirement savings with company match, life and disability insurance, and optional supplemental coverage

Paid time off, education reimbursement, and employee discount programs

Confidential counseling and resources for personal and work-life needs

Company

Rockline Industries, people who make it right

Rockline Industries was founded in 1976 and is headquartered in Sheboygan, Wisconsin.

Founded in 1976

Sheboygan, Wisconsin, USA

1001-5000 employees

http://www.rocklineind.com/

H1B Sponsorship

Rockline Industries, people who make it right has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (2)

2024 (2)

2022 (5)

2020 (1)