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Iso 11607 Jobs in Texas (NOW HIRING)

Ensure compliance with ISO standards, quality procedures, work instructions, and customer-specific requirements. * Coordinate and lead internal audits, external audits, customer audits, and ...

Quality Engineer

Greenville, TX · On-site

$70K - $90K/yr

Provides technical support for the development and implementation of ISO 9000 Quality Management systems in a Lean Continuous Process Improvement environment. Also, to provide quality engineering ...

Ensure compliance with ISO standards, quality procedures, work instructions, and customer-specific requirements. * Coordinate and lead internal audits, external audits, customer audits, and ...

Lead and continuously improve ISO 9001 & ISO 22000 Quality Management Systems * Oversee QC Lab operations, calibration programs, and test method development * Drive customer complaint resolution ...

Ensure compliance with ISO standards, quality procedures, work instructions, and customer-specific requirements. * Coordinate and lead internal audits, external audits, customer audits, and ...

Be Seen First

Ensure compliance with applicable international standards (e.g., ASTM, ISO, SAE, MIL-STD) during inspection and documentation. * Record inspection results accurately in quality documentation systems ...

Ensure compliance with ISO standards, quality procedures, work instructions, and customer-specific requirements. * Coordinate and lead internal audits, external audits, customer audits, and ...

Document inspection results accurately and maintain records in compliance with ISO 9001 standards. * Identify and report non-conformances, and assist in root cause analysis and corrective actions.

Showing results 21-40

Iso 11607 information

What is ISO 11607?

ISO 11607 is an international standard that specifies requirements and test methods for packaging materials and systems used to sterilize medical devices. It ensures that packaging maintains sterility up to the point of use and provides guidance on validation processes. The standard is divided into two parts: Part 1 covers requirements for materials and design, while Part 2 focuses on packaging process validation. Compliance with ISO 11607 is critical for manufacturers to ensure patient safety and meet regulatory requirements.

What skills and qualifications are needed to work with ISO 11607?

To thrive as an ISO 11607 Compliance Specialist, you need expertise in packaging validation, regulatory standards for sterile medical devices, and a background in engineering, quality assurance, or a related scientific field. Familiarity with technical tools such as validation protocols, statistical analysis software, and document control systems is typically required, as well as knowledge of ISO 11607-1 and ISO 11607-2 standards. Strong attention to detail, analytical thinking, and effective communication help ensure compliance and successful collaboration with cross-functional teams. These skills ensure that medical device packaging meets regulatory requirements, safeguarding patient safety and supporting product quality.

What challenges do professionals face when working with ISO 11607 compliance?

Professionals ensuring ISO 11607 compliance often face challenges in interpreting and applying the standard’s requirements to a variety of packaging materials and processes. Keeping up with evolving regulatory expectations, conducting thorough risk assessments, and validating packaging systems can be complex and time-consuming. Collaboration with cross-functional teams including R&D, quality assurance, and manufacturing is crucial to ensure that all packaging meets both regulatory and functional standards. Additionally, maintaining detailed documentation and responding to audit findings are key parts of the role.

What is the difference between Iso 11607 vs Packaging Technician?

AspectIso 11607Packaging Technician
CertificationsStandards for sterile packagingOften certified in packaging processes
Work EnvironmentManufacturing and sterile packaging facilitiesPackaging lines, production areas
Industry UsageMedical device and pharmaceutical packagingMedical device, pharmaceutical, and consumer goods
Primary FocusEnsuring packaging meets sterilization and safety standardsAssembling, inspecting, and packaging products

While Iso 11607 refers to standards for sterile packaging, a Packaging Technician focuses on executing packaging processes according to those standards. The technician ensures products are properly packaged, inspected, and ready for sterilization, aligning with Iso 11607 requirements to ensure safety and compliance.

What job categories do people searching Iso 11607 jobs in Texas look for?

The top searched job categories for Iso 11607 jobs in Texas are:

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 29 days ago


Dover Corporation rating

8.2

Company rating: 8.2 out of 10

Based on 25 frontline employees who took The Breakroom Quiz


Job description

Bearings Plus, part of Dover Precision Components, is hiring a Quality Supervisor. We offer competitive pay and benefits and the ability to be a key team member within our manufacturing organization. Be a part of a growing (organically and through acquisitions) and innovative company. Bearings Plus is the aftermarket arm of Waukesha Bearings, a leader in the repair, replacement and upgrade of fluid film bearings and seals. We are part of Dover Corporation, known for our marketplace leadership and stability.

The ideal candidate will possess strong experience in root cause analysis, ISO quality systems, supplier quality management, Lean Manufacturing, Six Sigma methodologies, and precision machining processes. This leader will work closely with Production, Manufacturing Engineering, Applications Engineering, Supply Chain, and Sales teams to improve product quality, reduce defects, strengthen supplier performance, and enhance customer satisfaction.

This position supervises approximately 4 Quality Technicians on 1st shift.

WHAT YOU’LL DO

We are seeking results-oriented Quality professional to lead quality assurance and quality management system activities within our turbomachinery repair and precision machining operation. This position is responsible for ensuring compliance with customer requirements, ISO standards, internal quality procedures, and regulatory requirements, while driving a culture of continuous improvement throughout the organization. Responsibilities include:

  • Lead daily quality assurance activities to ensure products and services meet customer, regulatory, and company requirements.
  • Supervise and develop Quality Inspectors while promoting a culture of accountability, continuous improvement, and operational excellence.
  • Serve as a key leader in maintaining and improving the company’s ISO Quality Management System (QMS).
  • Ensure compliance with ISO standards, quality procedures, work instructions, and customer-specific requirements.
  • Coordinate and lead internal audits, external audits, customer audits, and certification audits.
  • Drive root cause investigations using structured problem-solving methodologies such as 8D, 5 Why Analysis, Fishbone Diagrams, Fault Tree Analysis, and Corrective and Preventive Actions (CAPA).
  • Lead corrective action efforts and verify effectiveness of implemented solutions.
  • Analyze quality performance data and develop action plans to improve key quality metrics.
  • Partner with Manufacturing Engineering, Applications Engineering, and Production teams to reduce scrap, rework, customer escapes, and process variation.
  • Lead supplier quality initiatives including supplier audits, supplier corrective actions, supplier performance reviews, and supplier development programs.
  • Support incoming, in-process, and final inspection processes to ensure compliance with engineering drawings, specifications, and customer requirements.
  • Review and disposition nonconforming material, while ensuring timely containment and corrective actions.
  • Support customer complaint investigations and provide timely responses to customer quality concerns.
  • Develop and maintain quality metrics, dashboards, and Key Performance Indicators (KPIs).
  • Drive Lean Manufacturing and Six Sigma projects focused on reducing waste, improving process capability, and increasing customer satisfaction.
  • Promote and enforce workplace safety policies and procedures.

 

 

 

WHAT YOU’LL BRING

 

  • Bachelor’s degree in Engineering, Engineering Technology, or related field preferred. May consider 5+ years’ work experience with strong quality supervisory background in engineered component manufacturing environment(s).
  • Minimum of 5 years of quality experience within a machining, manufacturing, repair, or industrial environment.
  • Supervisory experience preferred. Team or project lead experience also considered.
  • Demonstrated experience leading root cause investigations and corrective action programs.
  • Strong working knowledge of ISO Quality Management Systems and audit processes.
  • Experience managing supplier quality programs and supplier performance improvement initiatives.
  • Strong understanding of quality tools, statistical analysis, process capability, and continuous improvement methodologies.
  • Proficiency in reading technical drawings.
  • Experience with ERP systems, quality databases, and manufacturing performance metrics.
  • Proficiency with Microsoft Office applications.
  • Strong leadership, communication, and organizational skills.
  • Lean Manufacturing certification or formal Lean training.
  • Experience with ISO 9001, AS9100, API Q1, or similar quality management systems.
  • Experience with Geometric Dimensioning and Tolerancing (GD&T).
  • Experience using Coordinate Measuring Machines (CMM), precision inspection equipment, and Statistical Process Control (SPC).

 

ALSO GREAT IF YOU BRING/ PREFERENCES

  • Six Sigma Green Belt, Black Belt, or equivalent certification.
  • Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or similar professional certification.
  • Experience in turbomachinery, rotating equipment, and/or bearing and seal repair, is preferred.
  • Experience with custom engineered components in a fast-paced manufacturing environment.

DOVER PRECISION COMPONENTS

Dover Precision Components ‘DPC’ (‘the Company’) is part of Dover Corporation’s (‘the Parent Company’) Pumps and Process solutions segment. DPC holds market leading positions globally and delivers performance-critical solutions across the oil & gas, power generation, marine, industrial, chemical and general processing markets. We design and manufacture mission-critical equipment components to deliver more affordable, cleaner energy solutions and enable manufacturers to operate more efficiently.

 

WE DELIVER CUSTOMER SUCCESS

Dover Precision Components delivers products and services that enhance performance, improve safety, reduce carbon emissions, and accelerate clean energy adoption, through collaborative Customer relationships, expert engineering, and an innovative culture. Our strong Company portfolio is comprised of long products and services offered under Cook Compression, Cook Mechanical Field Services, Waukesha Bearings, Waukesha Magnetic Bearings, Inpro/Seal, Bearings Plus, and FW Murphy Production Controls. Our global footprint reaches more than twelve locations in the Americas and more than six locations in Europe and China.

 

BUILDING POTENTIAL. SUSTAINING PERFORMANCE. BOOSTING FUTURES.

We are diligent in recognizing our employees’ needs and providing an enriching experience through professional developmental opportunities. Our authentic, collaborative company culture, combined with a competitive suite of health and welfare offerings, emulates who we are.

 

We consider several job-related, non-discriminatory factors when determining the pay rate for a position, including, but not limited to, the position’s responsibilities, a candidate’s work experience, a candidate’s education/training, the position’s location, and the key skills needed for the position.  Pay is one of the Total Rewards that we provide to compensate and recognize employees for their work.

Benefits for this position include: a 401(k) savings plan with employer contributions; medical, dental and vision insurance; wellness programs; health savings account, health care and dependent care flexible spending accounts; company paid short-term disability and long-term disability; company paid employee basic life and AD&D insurance; supplemental employee and dependent life insurance; optional accident, hospital indemnity and critical illness insurance; adoption, surrogacy, and fertility benefits and assistance; commuter benefits; parental, military, jury duty, and bereavement leaves of absence; paid time off, including business travel services; employee discounts; and an employee assistance program that includes company paid counseling sessions and legal services. Eligibility for benefits is governed by applicable plan documents and policies.

All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age, genetic information, or any other factors prohibited by law.

Attention Applicants: If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, please let us know. Likewise, if you are limited in the ability to access or use this online application process and need an alternative method for applying, we will determine an alternate way for you to apply. Please contact hr@doverprecision.comf for assistance with an accommodation. Kindly specify Job Requisition Number / Job Title and Location in response.

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