AG1 · 3 hours ago

Quality Assurance Engineer

Remote - US

Full-time

Remote

Mid, Senior Level

$88K/yr - $112K/yr

7+ years exp

Maximize your interview chances

FitnessHealth Care

Comp. & Benefits

Insider Connection @AG1

Discover valuable connections within the company who might provide insights and potential referrals.
Get 3x more responses when you reach out via email instead of LinkedIn.

Responsibilities

Partner with the Manager, Quality Systems to maintain Quality Management System (QMS) procedures and Standard Operating Procedures (SOPs) to ensure compliance with CFR, ISO, and other relevant quality management standards.

Apply statistical process control (SPC) methods to evaluate current processes and process changes on overall quality.

Monitor product and process performance metrics, identify trends (positive or negative), and take appropriate actions to ensure continuous improvement.

Maintain and analyze internal quality metrics (NCMR, SCRAP, & Rework) customer returns and failure rate data in depth to identify trends and areas for improvement.

Improve the overall quality performance and efficiency by identifying adverse trends, developing action plans, and implementing corrective and preventive measures.

Conduct through analysis of performance data, identify performance gaps, trends and improvement opportunities and provide recommendations to the Quality leadership team.

Establish and manage the process for Annual Product Reviews (APRs) to assess product performance and compliance over time.

Partner with the QC team to establish a Product Safety Committee which reviews, analyzes and determines actions resulting from tests, audit or consumer feedback.

Partner closely with Supplier Quality to assist with reviewing documentation provided by suppliers for accuracy and completeness; notify the Sr. Director of Supplier QA when suppliers do not provide the required documents or are out of compliance with Foreign Supplier Verification protocol.

Properly assess manufacturing environments, independently advise management on appropriate corrective/preventative actions designed to mitigate operational deficiencies identified in the investigative process using industry accepted analytical tools.

Interact regularly with third-parties including co-manufactures on to ensure compliance with quality standards, address any quality-related issues, and facilitate continuous improvement initiatives. Collaborate on process validations, and corrective action plans to maintain high standards of product quality and safety.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Quality Management Systems (QMS)Statistical Process Control (SPC)Code of Federal Regulations (CFR)International Organization for Standardization (ISO)Six SigmaASQ Certified Quality Engineer (CQE)Data collectionLeadership capabilitiesMinitabManufacturing processesQuality assurance testingProduct safety evaluations

Required

Bachelor’s degree in Engineering, Quality Management, or a related field is required.

A minimum of 7+ years of proven experience in a quality engineering role, with demonstrated expertise in Quality Management Systems (QMS), Code of Federal Regulations (CFR), International Organization for Standardization (ISO) standards, and Statistical Process Control (SPC) methodologies.

Familiarity with manufacturing processes, quality assurance testing, and product safety evaluations.

Solid knowledge of relevant regulatory standards such as

Proficiency in data collection, analysis, and statistical methods.

Excellent problem-solving skills with a track record of identifying root causes, developing effective corrective and preventive action plans, and successfully implementing solutions to address quality issues.

Strong communication skills, both written and verbal, with the ability to effectively convey complex information to cross-functional teams, stakeholders, and leadership.

Proven leadership capabilities with experience leading quality initiatives, driving change, and influencing others.

Excellent data collection and analysis skills, minitab.

Strong attention to detail, ensuring that all aspects of quality processes are thoroughly monitored and maintained.