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Iso 11607 Jobs in Michigan (NOW HIRING)

Quality Engineer

Plymouth, MI · On-site

$68K - $88K/yr

Responsible for reading and understanding the ISO-9001:2015, ISO-17025:2017, and ISO-14001 procedures. * Excellent organizational, analytical and communication skills. * Effective email and ...

Quality Engineer

Romulus, MI · On-site

$69K - $89K/yr

Following are the job duties: - Conduct quality inspections and analyze product specifications - Implement and maintain ISO 9001 standards - Oversee quality control processes to identify defects and ...

Quality Manager

Coopersville, MI · On-site

$71K - $104K/yr

Ranger Die is seeking a Quality Manager with a solid background in quality management systems - preferably ISO and IATF - as well as a proven record of capable leadership. This role manages a small ...

ISO 9001QMS). * Ensuretimelycreation, review, approval, andbaseliningofSQA deliverablesrequiredfor certification and customer releases. * Collaborate closely withProduct Engineering, Architects ...

New

Experience with ISO 13485 and ISO 14001 standards, Safety and OSHA/MIOSHA compliance management are a plus. Should have a thorough understanding of global material compliance directives such as REACH ...

Ranger Die is seeking a Quality Manager with a solid background in quality management systems - preferably ISO and IATF - as well as a proven record of capable leadership. This role manages a small ...

Quality Manager

Coopersville, MI · On-site

$71K - $104K/yr

Ranger Die is seeking a Quality Manager with a solid background in quality management systems - preferably ISO and IATF - as well as a proven record of capable leadership. This role manages a small ...

Experience with ISO 13485 and ISO 14001 standards, Safety and OSHA/MIOSHA compliance management are a plus. Should have a thorough understanding of global material compliance directives such as REACH ...

Experience with ISO 13485 and ISO 14001 standards, Safety and OSHA/MIOSHA compliance management are a plus. Should have a thorough understanding of global material compliance directives such as REACH ...

The site encompasses 40,000 sq. ft., including 15,000 sq. ft. of ISO 7 and ISO 8 cleanrooms certified to ISO 14644‑1:2015, enabling both high‑volume production and rapid prototyping in a ...

ISO 9001 Oversight:** Manage the ISO 9001 Quality Management System to ensure compliance, certification, and documentation.* **Audits & Compliance:** Lead internal and external ISO audits, address ...

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 are popular job titles related to Iso 11607 jobs in Michigan?

For Iso 11607 jobs in Michigan, the most frequently searched job titles are:

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

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

What cities in Michigan are hiring for Iso 11607 jobs?

Cities in Michigan with the most Iso 11607 job openings:

Quality Manager with Stamping Facility Experience

Amsted Automotive Group

Sterling Heights, MI

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 17 days ago


Job description

WHO WE ARE

At Amsted Automotive, we’re more than just a company—we’re a community of innovators, creators, and dedicated professionals who take pride in our work and each other. As an employee-owned organization, every team member has a vested interest in our success and shares in our achievements. This unique ownership culture fosters a collaborative, supportive environment where your ideas and contributions truly matter. Come join us and be part of a dynamic team that’s transforming the industrial and automotive industries while shaping the future of mobility!

WHAT YOU’LL DO

Key Responsibilities

  • Champion all Quality initiatives for the business
    • Reduce Cost of Poor Quality (COPQ) through targeted improvement initiatives.
    • PPM Defective Reduction
    • Drive problem-solving efforts using proven tools while establishing effective metrics to track results
    • Champion continuous improvement process projects in the plant to support internal and external Quality initiatives. 
  • Ensure Customer Satisfaction through established Quality initiatives
    • Function as the Voice of the Customer to ensure customer requirements and expectations are met.
    • Lead Corrective Action Process using Customer Corrective Action (CA) requirements, such as 8 D and 5 Why (both internal and external)
  • Conduct Management Review of the Quality System
    • Develop and maintain quality documentation (work instructions, check sheets, PFMEA).
    • Approve and administer compilation of PPAP submissions (internally and externally)
    • Responsible for successful completion of all quality certification audits
  • Execute all requirements of an effective inspection system
    • Ensure attainment and ongoing compliance with quality certifications, including ISO and IATF.
    • Responsible for successful completion of all quality certification audits
  • Execute all requirements of an effective inspection system
    • Evaluate production processes through Statistical Process Controls data
    • Confirm product shipped to customer meets customer requirements
    • Identify opportunities for cost savings, gains in efficiency and overall effectiveness
  • Develop and maintain supplier quality standards for raw materials and manufactured/purchased parts
  • Provide leadership, management, and development of team members.
  • Actively participate as the primary quality representative of the management team

WHAT YOU'LL NEED TO SUCCEED

  • Stamping environment experience
  • Demonstrated success at establishing and maintaining a Zero Defects mentality
  • Demonstrated leadership skills to include strong team orientation, honest, ethical, fact-based, acts with a sense of urgency, executes and achieves desired results.
  • Effective communication skills (oral and written) with the ability to communicate to all levels within the organization as well as customers regarding quality concerns.
  • Must have expert knowledge of Geometric Dimensioning and Tolerancing (GD&T)
  • Experienced Metrologist able to use quality tools to define measurement characteristics and part capability.
  • Strong statistical background including the use of SPC within the manufacturing process to measure and sustain capability.
  • Experience with ISO and IATF 16949 Quality Systems development, implementation, maintenance, and re-certification.
  • Manage a Customer Specific Requirements library and maintain awareness of CSR’s
  • Thorough understanding of APQP, PPAP, PFMEA’s and new product launches.
  • Knowledge of Quality System Basics, Fast Response, Early Part Containment and Six Sigma are helpful.
  • Proficient with Microsoft Office applications (especially Excel) and database applications
  • The best candidate will have excellent manual dexterity, ability to lift and carry up to 50 pounds occasionally. Work may require extended periods of sitting, standing, lifting, bending, and stooping.
  • Demonstrated excellent leadership skills with exceptional communication skills.
  • Excellent proficiency with essential software such as Microsoft Office 365.
  • Possess strong commitment to team environment dynamics with the ability to lead, teach and develop a team.
  • Experience in environmental, health and safety, and quality management in a fast paced, automotive manufacturing environment
  • IATF16949 and ISO 9001 Management Representative, possessing and maintaining working knowledge of IATF16949, ISO 9001, & ISO 45001, and customer specific compliance criteria at all current levels.

Education

  • Preferred: Bachelor’s degree in engineering, Quality, or Manufacturing Engineering

WHAT’S IN IT FOR YOU

We create a supportive environment where employees thrive! With a range of benefits designed to enhance your health, well-being, and financial security, we’re here to support you every step of the way. Join us and experience the exceptional rewards that make Amsted Automotive a great place to work! 

Health And Wellness

  • Medical Insurance
  • Dental and Vision Insurance
  • Prescription Drug Benefits
  • Wellness Reimbursement
  • Telehealth
  • Onsite health screenings
  • Mental health resources
  • Employee Assistance Program that includes counseling and support services for mental health, family support, financial advice, legal guidance, and more

Financial Benefits

  • Competitive Salaries
  • Employee Stock Ownership Plan
  • Annual Bonus Opportunity
  • 401k with Company Match
  • Health Savings Account with Company Contribution
  • Life and Disability Insurance

 Work-Life Balance

  • Paid Time Off
  • Parental Leave
  • 14 Annual Company Paid Holidays

Professional Development

  • Training Programs
  • Education Expense Reimbursement
  • Career Advancement Opportunities

Additional Benefits

  • Pet Insurance and Discount Program
  • Legal Insurance
  • Employee Discounts
  • Recognition and Rewards
  • Community Involvement
  • Workplace Giving Matching Gift Program