Manager, Quality Assurance Job at CHS Inc. (Fargo)

Manager, Quality Assurance

X-Bow Systems is seeking a Quality Assurance Manager to lead and manage all aspe...

Location

United States , Luling

Salary:

Not provided

X-Bow Systems

Expiration Date

Until further notice

Requirements

Proficient in Microsoft Office Suite or related software
Excellent problem-solving skills
Strong written and verbal communication skills for preparing reports, documenting processes, and presenting findings
Comfortable working in cross-functional teams, including engineering, manufacturing, and supply chain
Familiarity with document control processes and maintaining quality records
Exceptional analytical, strategic, and critical thinking skills
Ability to prioritize and coordinate multiple tasks within critical deadlines
Attention to detail and accuracy
B.S./B.A. in Engineering, Sciences or Manufacture Applied disciplines with a minimum of 15 years of relevant experience
M.S. in Engineering or Sciences may substitute for years of experience

Job Responsibility

Develop, plan, and implement quality strategies, methods, and systems to support production while ensuring compliance with Government contracts, as applicable
Provide leadership and coordination for the Operations team, including Manufacturing and Quality & Mission Excellence
Act as a liaison between the Operations team and other organizational departments
Ensure products are manufactured, tested, and delivered on schedule to meet contract deadlines
Oversee demand inputs to coordinate, forecast, and report on performance, risks, and mitigation plans to factory management
Coordinate strategic planning across programs for common parts/builds and equipment utilization
Facilitate and/or support program meetings, provide status updates and present Operations progress to site leadership
Act as a manager within the Production Operations team, providing training and mentoring to team members
Support project and manufacturing planning, including personnel assignments, work efforts, customer requirements, deliverables development, and tracking
Assist with Contract Review, Purchase Orders, Receiving Inspection, and Inventory management activities related to program procurements

Fulltime

Manager, Quality Assurance

The Manager, Quality Assurance is responsible for overseeing the Quality Managem...

Location

United States , Lenexa

Salary:

Not provided

Avanos

Expiration Date

Until further notice

Requirements

Minimum 5–7 years in a regulated manufacturing industry (medical device, pharma, biotech, or similar)
Bachelor’s degree in engineering, Quality, Life Sciences, or related field
Hands-on experience maintaining product quality and QMS performance while expanding a manufacturing operation from one shift to two (or similar multi-shift expansion)
Deep knowledge of FDA QSR/QSMR, ISO 13485, and medical-device quality principles
Proven experience managing audits (FDA, ISO, customers) and regulatory compliance activities
Strong background in complaint handling, CAPA, nonconformance management, and quality metrics
Experience supporting or managing validations (IQ/OQ/PQ)
Demonstrated ability to lead and develop quality teams
Excellent written and verbal communication skills

Job Responsibility

Maintain, oversee, and continually improve the ISO 13485–compliant and FDA QSMR/QSR–compliant QMS
Develop, revise, and implement QMS procedures, work instructions, and controlled documents
Ensure QMS performance and control during operational expansion
Ensure product quality for sterile disposable medical products, including in-process inspections, final inspections, packaging operations, sterilization and environmental controls
Monitor and analyze quality trends across all shifts
drive investigations and corrective actions for nonconformances, scrap, and process deviations
Partner with Operations and Engineering to support validation and re-validation activities (IQ/OQ/PQ) and continuous improvement projects
Lead and direct sterilization compliance and performance
Lead and direct cross-functional evaluation of process and design changes
Lead and direct employee training programs

What we offer

comprehensive and competitive range of benefits
generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting
benefits on day 1
free onsite gym
onsite cafeteria
uncapped sales commissions

Fulltime

Senior Manager Quality Assurance: Incoming Quality and Warehouse

At Amgen, if you feel like you’re part of something bigger, it’s because you are...

Location

United States , New Albany

Salary:

144021.45 - 194852.55 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of Quality/Manufacturing/Engineering experience
Master's degree and 6 years of Quality/Manufacturing/Engineering experience
Bachelor's degree and 8 years of Quality/Manufacturing/Engineering experience
Associate's degree and 10 years of Quality/Manufacturing/Engineering experience
High school diploma / GED and 12 years of quality/Manufacturing/Engineering experience
minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources

Job Responsibility

Lead, coach and develop the QA team, responsible for quality oversight of Incoming Quality, Warehouse Operations, Distribution and Facility and Engineering. Team scope includes disposition of product, materials and components, including on-the-floor support, record review, quality oversight of deviation investigations and changes, document approval
Ensure AOH product is manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Amgen standards, and applicable regulations
Drive investigations and resolution of deviations, ensuring timely, thorough, and compliant outcomes
Lead and participate in Quality Risk Assessments
Provide Quality input to support project or operational design decisions
Build organization according to hiring strategy that supports our growth. Partner with HR to recruit, coach, develop, motivate, and retain staff. Ensure ongoing organizational structure capable of adapting to evolving business needs
Provide oversight to ensure that Amgen Quality Management System is implemented and maintained in accordance with corporate standards
Track performance and drive continuous improvement in the performance and delivery of quality outputs in alignment with Quality strategies
Develop strategies in support of regulatory inspections and site audits
Serve as quality representative to regulatory authorities, Amgen Corporate auditors, and 3rd Parties

What we offer

health and welfare plans for staff and eligible dependents
financial plans with opportunities to save towards retirement or other goals
work/life balance
career development opportunities
comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
discretionary annual bonus program
stock-based long-term incentives
award-winning time-off plans
flexible work models where possible

Fulltime

Quality Assurance Manager

This is where you make a difference in our patients' safety. As a member of the ...

Location

United States , Saint Paul

Salary:

112000.00 - 154000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

BS in science or engineering
5+ years' experience in Quality, Manufacturing, Engineering, or related field which should include 2+ years of supervisory experience in Medical Device industry
Thorough knowledge of applicable procedures, specifications, regulations, and standards
Strong leadership skills and demonstrated success in managing mid-to-large teams
Capable of managing in matrix and ability to interact successfully with multi-functions globally
Strong analytical and problem-solving skills
Ability to manage/supervise a team of employees
Good communication and leadership skills
Good interpersonal/communication/influencing/negotiation skills
Good project management skills

Job Responsibility

Implementation and improvement of Quality Processes that will ensure compliance with Regulations, Corporate and Local procedures, and specifications
Interfaces with regulators during regulatory inspections/ audits
Support change control activities for manufacturing operations
Manage the release process, inspection, and batch release activities
Oversee, initiate, investigate and approve non-conformance report activities as needed
Develop and analyze statistical data and product specifications to determine present standards and establish proposed finished product's quality and reliability expectancy
Apply standard operating practices and problem-solving methodology across the organization
Serve as role model and coach employees at all levels in the application of best practices
Drives continuous improvement of processes and systems locally as well as deployment of such divisional and corporate initiatives with the objective of achieving quality, reliability, and cost improvements
Responsible for adherence to specifications and procedures that have been established to ensure product quality in area of responsibility

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts

Fulltime

Quality Assurance Manager

We are looking for a Quality Assurance Manager to lead quality programs for a ma...

Location

United States , Dallas

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

5+ years of experience in quality assurance within a manufacturing environment, including leadership responsibility
Demonstrated knowledge of quality systems, methodologies, and standards, with practical experience supporting ISO 9001 and related certifications
Experience conducting audits, managing findings, and leading root cause analysis with corrective and preventive action follow-through
Strong understanding of supplier quality management, performance measurement, and cross-functional collaboration with purchasing and operations
Ability to analyze quality data, track cost-of-poor-quality indicators, and use findings to drive process improvement
Proven leadership skills with the ability to coach teams, influence stakeholders, and promote a culture of quality
Familiarity with quality management tools and systems, including ERP or manufacturing quality platforms such as IQMS
Strong written and verbal communication skills with the ability to develop procedures, training materials, and audit documentation

Job Responsibility

Lead the quality function by supervising technicians and related staff, setting priorities, and ensuring daily activities support production and customer expectations
Establish annual quality objectives that support broader business priorities and translate them into measurable departmental plans
Administer and sustain certification efforts for key management standards, including ISO 9001, ISO 14001, and ISO 18001, while maintaining compliance with documented quality processes
Deliver training and guidance that helps employees understand quality procedures, system requirements, and their role in maintaining standards
Direct investigations related to customer complaints, warranty concerns, returns, and internal nonconformances, ensuring corrective and preventive actions are completed effectively
Partner with teams across the organization to create, refine, and maintain process documentation, operating procedures, and quality records
Plan and conduct internal audits, document findings, close out observations, and prepare the organization for external audits and certification reviews
Develop and monitor supplier quality performance metrics, collaborate with purchasing on scorecards, and build strong working relationships with suppliers to improve results
Support new product launches and product modifications by confirming that required quality characteristics, controls, and compliance expectations are met
Provide quality-focused direction to production operations while reinforcing safe, efficient, and consistent manufacturing practices

What we offer

medical
vision
dental
life and disability insurance
401(k) plan

Quality Assurance Manager

BlueWater Federal is looking for a Quality Assurance Manager to support the SEWS...

Location

United States , Colorado Springs

Salary:

95000.00 - 120000.00 USD / Year

BlueWater Federal Solutions

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, IT, Operations, Quality, or related field (or equivalent work experience).
7+ years of QA experience supporting DoD operations, O&M, or mission critical systems.
Must have an active Secret clearance.
Experience executing quality oversight on contracts with PWS aligned deliverables.
Experience supporting high availability systems similar to SEWS 3’s mission construct.
Experience with engineering systems and documentation to include rack elevations, topologies, and other technical documentation.

Job Responsibility

Document customer praise, milestones completed, process improvements, cost avoidance, reduced defects, faster turnaround, and operational wins using quantitative and/or qualitative evidence.
Develop and maintain a program quality dashboard to track quality status, trends, and current/future quality items of interest.
Prepare monthly quality summaries for internal leadership review and in preparation for PMRs and QPIRs.
Conduct internal quality audits of program artifacts, SOPs, checklists, processes, compliance, etc. Chair the Quarterly Quality Team (QQT) meeting where quality objectives, initiatives, audits, areas for concern, and action items can be discussed and assigned. Follow up with stakeholders to ensure compliance with quality standards.
Lead program process improvement efforts to identify broken, unclear, or inconsistent processes across the program.
Facilitate root cause analysis for recurring issues, such as late deliverables, inaccurate reports, missed handoffs, or discrepancies.
Establish a continuous improvement backlog prioritized by risk, customer impact, and contract importance.
Develop, maintain, and enforce the SEWS 3 Quality Control Plan in alignment with the PWS and OM&S mission requirements.
Implement quality processes across O&M, cybersecurity, engineering, site support, and training activities to ensure compliance with PWS requirements.
Manage quality reviews of all deliverables including documents, spreadsheets, training materials, and drawings for accuracy, configuration compliance, and contractual alignment.

What we offer

medical insurance
dental insurance
vision insurance
401k matching
employee stock purchase program
life insurance
paid time off

Fulltime

Sr Manager, Quality Assurance

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Cleveland

Salary:

136000.00 - 170000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Microbiology, Biology, Chemistry, or Engineering, or equivalent experience, required
5+ years of Engineering/Manufacturing/Quality experience required, with 3-5 years of leadership experience

Job Responsibility

Lead quality oversight for the Devices areas
Develop, assign, and implement systems, procedures, and policies to ensure compliance with ISO Standards, cGMP's, FDA regulations, and company policies
Conduct audits and implement changes to specifications, SOPs, and forms for regulatory compliance and process improvement
Ensure product compliance through established inspection criteria and procedures
Coordinate inspection activities throughout the production cycle
Analyze statistical data and product specifications to determine and improve quality standards
Prepare and submit reports to Managers and other Departments or Agencies as required
Communicate quality philosophy to key personnel
Actively participate in quality management teams within the organization
Manage and support area associates, encouraging a teamwork environment

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts

Fulltime

Sr Manager, Quality Assurance

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Cleveland

Salary:

136000.00 - 170000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Microbiology, Biology, Chemistry, or Engineering, or equivalent experience, required
5+ years of Engineering/Manufacturing/Quality experience required, with 3-5 years of leadership experience
FDA regulated manufacturing experience preferred
Six Sigma Green Belt Certification or industry-standard equivalent preferred
Project Management skills and experience are preferred
Experience and skills in Lean Manufacturing are preferred
Applicants must be authorized to work for any employer in the U.S. We cannot sponsor or transfer sponsorship of an employment visa.

Job Responsibility

Lead quality oversight for the Devices areas
Develop, assign, and implement systems, procedures, and policies to ensure compliance with ISO Standards, cGMP's, FDA regulations, and company policies
Conduct audits and implement changes to specifications, SOPs, and forms for regulatory compliance and process improvement
Ensure product compliance through established inspection criteria and procedures
Coordinate inspection activities throughout the production cycle
Analyze statistical data and product specifications to determine and improve quality standards
Prepare and submit reports to Managers and other Departments or Agencies as required
Communicate quality philosophy to key personnel
Actively participate in quality management teams within the organization
Manage and support area associates, encouraging a teamwork environment

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts

Fulltime

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Manager, Quality Assurance

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