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Iso 11607 Jobs in Florida (NOW HIRING)

Quality Engineer

Merritt Island, FL · On-site

$65K - $84K/yr

Strong knowledge of ISO and QMS standards, including ISO 9001, and their application in manufacturing and production settings. * Hands-on experience with root cause analysis, corrective actions (CAPA ...

Maintains a quality organization at the cutting-edge with DOE, SPC, ISO, RGT, RDT, RQT, PRAT and Lean Six Sigma technique proficiencies * Interacts both vertically and horizontally in a way that ...

Quality Engineer

Merritt Island, FL · On-site

$65K - $84K/yr

Strong knowledge of ISO and QMS standards, including ISO 9001, and their application in manufacturing and production settings. * Hands-on experience with root cause analysis, corrective actions (CAPA ...

Familiarity with ISO 13485 and ISO 17025 standards is considered a plus. * Strong technical and engineering aptitude, with the ability to quickly learn, adapt, and apply new processes and ...

Position SummaryQuality Manager with extensive leadership experience in ISO 9001 and AS9100 compliant Quality Management Systems (QMS) within electronics manufacturing environments. Proven expertise ...

Lead the Thomasville site through ISO 9001 certification Customer Returns: * Manage Quality RMAs and drive corrective actions Continuous Improvement: * Lead initiatives to improve quality performance ...

Takes ownership, leads, and manages a program for the initial successful ISO-9000 certification of the local site operations including creation and maintenance of the ongoing Quality Management ...

Takes ownership, leads, and manages a program for the initial successful ISO-9000 certification of the local site operations including creation and maintenance of the ongoing Quality Management ...

Position Summary Quality Manager with extensive leadership experience in ISO 9001 and AS9100 compliant Quality Management Systems (QMS) within electronics manufacturing environments. Proven expertise ...

Our organization is certified to ISO 9001, ISO 14001, ISO 27001, and SOC 2 Type II standards, reflecting our commitment to quality, security, operational excellence, and customer success.

Position Summary Quality Manager with extensive leadership experience in ISO 9001 and AS9100 compliant Quality Management Systems (QMS) within electronics manufacturing environments. Proven expertise ...

Showing results 41-60

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 Florida?

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

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

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

What cities in Florida are hiring for Iso 11607 jobs?

Cities in Florida with the most Iso 11607 job openings:

Infographic showing various Iso 11607 job openings in Florida as of July 2026, with employment types broken down into 1% As Needed, 16% Full Time, 31% Part Time, 1% Temporary, 33% Contract, and 18% Nights. Highlights an 92% Physical, 5% Hybrid, and 3% Remote job distribution.

Quality Manager-Tampa, Florida

Sypris Electronics LLC

Ruskin, FL • On-site

Full-time

Posted yesterday

New


Job description

Job Description
The Quality Manager establishes, implements and maintains processes and programs that yield high quality products while creating and maintaining both a quality-centric and quality-focused culture for all Sypris Electronics' production activities.
RESPONSIBILITIES:
  • Ensures customer's satisfaction with Sypris Electronics products
  • Implements the Quality Department strategic initiatives to successfully meet current and future operational requirements
  • Participates and contributes to the implementation and successful performance against the business AOPImplements Quality strategies which support maintaining and improving operational competitiveness
  • Develops an annual business plan designed to identify objectives and actions needed to improve overall quality performance and meet customer and business objectives
  • Establishes goals and objectives for the Quality team that stretch boundaries by detailing specific continuous improvement activities focused on enhancing internal process and test yields
  • Ensures internal processes and programs produce products that meet or exceed customer's expectations
  • Creates and maintains both a quality-centric and quality-focused culture for all Sypris Electronics' production activities throughout the organization
  • Maintains a quality organization at the cutting-edge with DOE, SPC, ISO, RGT, RDT, RQT, PRAT and Lean Six Sigma technique proficiencies
  • Interacts both vertically and horizontally in a way that commands both personal respect and mission acceptance
  • Maintains effective working relationships with DCMA as well as current and future customers
  • Evaluates the Quality processes to ensure alignment with the integrity and efficiency standards set by Sypris
  • Reports the status of quality control and operations to senior leadership and required regulatory agencies
  • Develops, manages, and monitors product quality performance, reporting monthly and yearly comparisons, statistics and key performance indicators
  • Directs internal and external audit functions to ensure compliance with AS9100/ISO 9001:2015
  • Administers all Human Resources programs and policies (including selection, promotion, transfers, salary administration and termination) without regard to race, religion, sex, national origin, age or handicap)

REQUIREMENTS:
  • Bachelor's Degree in Electrical, Manufacturing or Industrial Engineering
  • Seven or more years related experience
  • In depth knowledge of electronic manufacturing processes including SMT, through-hole technology, assembly and test, and box build assembly
  • Thorough knowledge of quality management systems and procedures including ISO, ASQ, NADCAP as well as ensuring the company's QMS system complies with all external (independent and customer) requirements and audits
  • Thorough knowledge of quality procedures and methodologies, including ISO, Six Sigma, Lean, and failure reporting and corrective action system
  • Excellent problem-solving skills, including Root Cause/Failure Analysis, and Corrective Action process
  • Strong understanding of APQP, FMEAs, Control Plans, Statistical Methods, Measurement Systems Analysis and First Article Approval process
  • Excellent leadership, management and negotiating skills
  • Excellent computer and communication skills (written and oral) and experience with statistical process control tools
  • Ability to obtain a U.S. Government granted Security clearance, if required
  • Some travel required on an as needed basis

Sypris Electronics, LLC provides goods and services to the U.S. Government and other prime contractors and is obligated by its contracts with those entities, as well as by various federal laws and regulations regarding security and export control, to restrict access to certain goods, services, and/or any related information. Accordingly, Sypris Electronics has a policy of only hiring U.S. citizens. Upon employment all employees will have to provide evidence verifying U.S. citizenship.
Our company uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.everify.gov.
Pre-employment drug screening and criminal background check required.
Sypris Electronics is an Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.