Sr. Quality Engineer

BioMed Laboratories LLC; Mesquite (TX); On-site; USD 111,000 - 150,000; Full time

Benefits offered by this job

Health, dental and vision insurance

401(k) retirement plan with company匹配

Job summary

BioMed Laboratories, LLC seeks a Sr. Quality Engineer to lead quality improvements and ensure QMS compliance in a medical device environment. You will drive CAPA programs, write validation plans, and collaborate with production to reduce defects.

The role requires a bachelor’s in engineering and 8+ years in quality systems, with experience in FDA/ISO standards, FMEA, SPC, and lean six sigma. Location: Dallas, TX, full-time.

Qualifications

• Bachelor's degree in Computer Engineering, Systems and Industrial Engineering, or related field.
• Eight years of senior quality systems/QA experience in medical devices or related industries.
• Experience with CAPA, RCA, SPC and regulatory standards (FDA/ISO).

Responsibilities

• Lead quality improvement efforts to remove bottlenecks and drive CAPA effectiveness.
• Develop and maintain QMS processes, documents, and quality plans.
• Collaborate with production to reduce defects and scrap via root-cause action.
• Create and analyze product and process metrics to support quality decisions.
• Coordinate audits with regulators, notified bodies, and clients as needed.
• Mentor junior quality engineers and ensure regulatory compliance.

Skills

CAPA & RCA tools

Statistics & SPC

FMEA

DOE

Measurement systems analysis (MSA)

QMS implementation

Regulatory knowledge (FDA/ISO)

Lean Six Sigma

Data analysis (Excel, Minitab)

Education

Bachelor's degree in Computer Engineering, Systems and Industrial Engineering

Tools

Minitab

Excel

Job description

Mativ is a global leader in specialty materials headquartered in Alpharetta, Georgia. The Company offers a wide range of critical components and engineered solutions that connect, protect, and purify our world.

NOTICE OF FILING

Employer: BioMed Laboratories, LLC

Job Title: Sr. Quality Engineer

Job Location: 8181 Eastpoint Dr., Suite 300, Dallas, TX 75227

Job Type: Full-time, 40 hours a week, Monday - Friday

Duties:

• Lead Quality improvement efforts by identifying quality bottlenecks and corrective measures to eliminate this.
• Writing CAPAs, methods to capture quality metric data and performs appropriate analysis to effectively monitor and enhance the Quality Management System (QMS).
• Assure new or modified processes or documents conform to quality standards and establishes compliance with the quality system.
• Work with Production Management to reduce and control Manufacturing process defects (scrap, nonconforming material, and customer complaints) by leading efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions.
• Develop and implement product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses, FMEAs in conjunction with other product development team members.
• Work with Process Engineer to develop and implement Process Monitoring Systems by identifying critical process and devising methods to reduce process variation in order to reduce/eliminate the cause of defects.
• Evaluate product performance, identify areas of improvement, and recommend solutions to ensure product quality.
• Analyze quality control data and develop reports to identify trends and recommend corrective actions.
• Coordinate and collaborate with internal departments to resolve quality issues.
• Interfacing with Regulatory, Notified Body or Client Audits and assessing possible findings and responding to these in a timely manner.
• Ensure compliance with applicable industry standards and regulations.
• Stay up to date with best practices and industry developments related to quality assurance.
• Train and mentor junior quality assurance engineers.

Requirements:

• Bachelor's degree (or foreign equivalent) in Computer Engineering, Systems and Industrial Engineering, or related field of study and eight (8) years of experience as as a Sr. Quality Systems Engineer, Sr. Quality Assurance Engineer -Design Transfer, Quality Assurance Engineer, Quality Systems Manager, Quality Systems Coordinator, Site CAPA Coordinator, or related role where experience was gained. Also requires 8 years of experience in the following:
  • Quality Assurance experience, auditing experience and demonstrated knowledge using quality tools/methodologies such as process and equipment validations (IQ/OQ/PQ);
  • Experience applying CAPA and root-cause analysis tools (RCA) tools such as 5-whys, Fishbone/Ishikawa, FMEA, DOE and fault-tree analysis, and other structured problem-solving methods, as well as applying statistical process control (SPC) methodologies including control charts, process capability analysis (Cp, Cpk, Pp, Ppk), capability studies for special-cause versus common-cause variation, Pareto analysis, trend analysis, and gauge R&R (MSA), and the development and application of sampling plans (ANSI/ASQ Z1.4, ISO 2859), using data analysis software tools such as Minitab and Excel;
  • FMEA development and maintenance;
  • FDA, ISO and global regulatory standards applicable to medical devices, OTC drugs and cosmetics to ensure compliance across product development and QMS activities;
  • Implementing, maintaining, and continuously improving QMS frameworks to drive consistent product quality and operational excellence;
  • Lean and Six Sigma methodologies, with practical experience applying process improvement tools to improve product quality and operational performance;
  • Applying regulatory and industry standards including 21 CFR Part 820, ISO13485, 21 CFR Part 210/211 and 21 CFR Part 11;
  • Supporting manufacturing and quality activities for medical devices, OTC drugs or cosmetics, including understanding of specific cGMP (and other regulatory) requirements and standards; and
  • Implementing and maintaining Quality Management System (QMS) elements such as Design Controls or Non-Conformances, CAPA, Complaint Handling and Document Control.

Salary: $130,728 per year

THIS NOTICE IS BEING PROVIDED AS A RESULT OF A FILING OF AN APPLICATION FOR PERMANENT ALIEN LABOR CERTIFICATION FOR THE JOB OPPORTUNITY SET FORTH HEREIN. ANY PERSON MAY PROVIDE DOCUMENTARY EVIDENCE BEARING ON THE APPLICATION TO THE CERTIFYING OFFICER OF THE U.S. DEPARTMENT OF LABOR AT THE FOLLOWING ADDRESS:

U.S. Department of Labor

Employment and Training Administration

Office of Foreign Labor Certification

200 Constitution Avenue NW, Room N-5311

Washington, DC 20210

WHAT WE OFFER

At Mativ, our benefits reflect how much we value and care for each other. We know that employees and their families have unique needs, so our comprehensive benefits offer flexibility, quality, and affordability. Here are just a few of the ways we support your well-being and that of your loved ones:

• Medical, dental and vision insurance
• Consumer-Driven Health Plan (CDHP)
• Preferred Provider Organization (PPO)
• Exclusive Provider Organization (EPO)
• Company-paid basic life insurance and Additional voluntary life coverage
• Paid vacation and competitive personal time off
• 401(k) savings plan with company match
• Employee assistance programs - available 24/7 to you and your family
• Wellness and Work Life Support - career development and educational assistance

ABOUT MATIV

Mativ Holdings, Inc. is a global leader in specialty materials headquartered in Alpharetta, Georgia. The company connects, protects, and purifies the world every day through a wide range of critical components and engineered solutions that solve our customers' most complex challenges. We manufacture on three continents and generate sales in nearly 100 countries through our family of business-to-business and consumer product brands. The company's two segments, Filtration & Advanced Materials and Sustainable & Adhesive Solutions, target premium applications across diversified and growing end-markets, from filtration to healthcare to sustainable packaging and more. Our broad portfolio of technologies combines polymers, fibers, and resins to optimize the performance of our customers' products across multiple stages of the value chain. Our leading positions are a testament to our best-in-class global manufacturing, supply chain, and materials science capabilities. We drive innovation and enhance performance, finding potential in the impossible.

Mativ and its subsidiaries are Equal Opportunity Employers. Qualified applicants will be considered without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.