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Iso 11607 Jobs in Minnesota (NOW HIRING)

Own the global corrective and preventive action program related to ISO, ensuring timely, comprehensive issue resolution and effective root cause action tracking across 32+ locations. * Oversee ...

Own the global corrective and preventive action program related to ISO, ensuring timely, comprehensive issue resolution and effective root cause action tracking across 32+ locations. * Oversee ...

Quality Manager

Minneapolis, MN · On-site

$100K - $120K/yr

Support utilization of ISO and QMS systems cost-effectively * Utilize APQP/PPAP, process flow maps, FMEAs, control plans and measurement system evaluations to support Quality Standard requirements

This position offers the opportunity to influence company-wide quality strategy, strengthen ISO compliance, support new product development, and build a culture of accountability and continuous ...

Support and maintain ISO standards. * Ensure that organizational product quality levels are met utilizing company metrics and visuals to heighten employee awareness downstream. * Interface with all ...

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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 Minnesota?

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

What cities in Minnesota are hiring for Iso 11607 jobs?

Cities in Minnesota with the most Iso 11607 job openings:

Senior Packaging Engineer

Arden Hills, MN • Hybrid


Boston Scientific
Medical Equipment and Supplies Manufacturing • 10K+ employees

8.5

Company rating: 8.5 out of 10

Based on 120 frontline employees who took The Breakroom Quiz

32nd of 545 rated manufacturers

People enjoy working here

Good employer

Recommended by students


Full-time

Posted 24 days ago


Job description

Additional Location(s): US-MN-Arden Hills

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions.           

About the role:

 

Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day, and recognized by Forbes as one of the Best Workplaces for Engineers in 2026, reflecting a culture where engineers do meaningful work.

Serving as the technical SME, the Sr, Packaging Engineer leads packaging engineering activities and partners with global sustaining engineering teams in developing new processes, packaging materials, technologies, and equipment to drive sustaining initiatives for the Interventional Cardiology & Vascular Therapies (ICVT) and Interventional Oncology & Embolization (IO&E) divisions.  This role works independently to develop, direct, and execute plans for complex projects and collaborates with cross-functional teams to improve product performance, quality, operational efficiency, and overall business value.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include:

  • Serving as a trusted resource to provide technical leadership and consultation to cross-functional teams and external partners; cultivate strong partnerships with suppliers, testing laboratories, customers, and business stakeholders 
  • Leading packaging engineering activities to support sustaining and continuous improvement initiatives including cost reduction, manufacturing transfers, supplier and/or product changes; ensure compliance with design controls and regulatory requirements
  • Defining technical objectives to lead and support cross-functional projects; manage risks documentation, and communicate project results using technical reports and presentations
  • Facilitating qualification and testing activities (e.g. transportation, sterilization, aging, and package integrity evaluations) to develop, validate, and implement packaging solutions that meet applicable industry standards
  • Analyzing complex packaging, manufacturing, and field performance issues to identify root causes; apply engineering principles to implement corrective actions and resolve issues
  • Compiling, analyzing, and reporting research and operational test data to define technical specifications for new and modified packaging products, processes, and materials
  • Assessing emerging technologies, packaging materials, and manufacturing processes to improve product performance, quality, sustainability, and operational efficiency
  • Supporting onboarding activities and sharing technical knowledge to train, mentor and develop engineers; promote continuous learning and engineering excellence
  • Ensuring compliance with the Boston Scientific Quality System, Quality Policy, and all applicable regulatory, quality, and documentation requirements

Required qualifications:

  • Bachelor's degree in engineering or STEM-related discipline with at least 5 years of Packaging R&D experience
  • Minimum of 3 years working in medical device, pharmaceutical or similarly regulated industry
  • Strong technical knowledge of packaging materials, manufacturing processes, risk management, design controls, and product lifecycle management within a regulated quality system
  • Understanding of ISO 11607, relevant ASTM and ISTA standards and quality system controls (e.g. user needs, design inputs/outputs, verification/validation, etc.)
  • Critical-thinking and problem-solving skills
  • Ability to travel up 10% globally

 

Preferred qualifications:

  • Bachelor's degree in Packaging Engineering
  • Experience with packaging processes and equipment qualification
  • Skilled in resolving complex problems through root cause analysis, experimental design, and statistical methods to support data-driven decisions
  • Strong organizational skills with ability to manage multiple projects and prioritize competing tasks
  • Results-driven with ability to work independently to plan, schedule, and execute project activities necessary to meet timelines
  • Effective communication and presentation skills; ability to communicate with individuals on all levels
  • Strong interpersonal skills with ability to build relationships and collaborate with global teams

Requisition ID: 633758 

Minimum Salary: $ 85000 

Maximum Salary: $ 161500 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more atwww.bostonscientific.comand follow us onLinkedIn.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.  The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.  


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About Boston Scientific

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As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen.

Industry

Medical equipment and supplies manufacturing, manufacturing and construction

Company size

10,000+ Employees

Headquarters location

Marlborough, MA, US

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Benefits

Hours and flexibility

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