Top 41 Ii material quality assurance Jobs in Westminster, Co

Quality Engineer
LivaNova —Arvada, CO
- $85,000 - $95,000 a year
- Full-time
- Mid-level
- Math
- Travel
Research Associate I/II
KBI Biopharma —Boulder, CO
- $55,000 - $80,000 a year
- Full-time
- Master's degree
- Bachelor's degree
- Continuous improvement
- Paid holidays
- Health insurance
Quality Engineer II
Sierra Space —Englewood, CO
- $80,898.00 - $111,255.75 a year
- Full-time
- Mid-level
- Analysis skills
- Bachelor's degree
- Health insurance
- Dental insurance
Lab Technician II
Leprino Foods —Denver, CO
- $25.21 - $28.33 an hour
- Full-time
- Computer literacy
- Basic math
- Pass drug screening
- Profit sharing
- Wellness program
Quality Inspector Night Shift
Barber-Nichols LLC —Arvada, CO
- $30 - $43 an hour
- Overtime
- Writing skills
- Mid-level
- 3 years
- Profit sharing
- Paid jury duty
Quick Apply
8d
Manufacturing Associate I/II
KBI Biopharma —Boulder, CO
- $26.44 - $41.78 an hour
- Full-time
- Mid-level
- High school diploma or GED
- Military encouraged
4d
PMT II Working Zone Proctor
University of Colorado —Aurora, CO
- $4,955 - $5,946 a week
- Weekends as needed
- Background check
- Ability to walk for extended periods
- Pass drug screening
- Paid training
- Disability insurance
1d
Category Manager II, Direct Materials (DIM)
Philip Morris International U.S. —Aurora, CO
- $140,250 - $187,000 a year
- Full-time
- English
- Quality control
- Business Administration
- Commuter assistance
- Health insurance
EP Technologist
HCA HealthONE Aurora —Aurora, CO
- $37.26 - $55.91 an hour
- Overtime
- Adults
- Mid-level
- Adolescents
- Employee stock purchase plan
- Disability insurance
Quick Apply
9d
Cardiovascular Specialist RTR RCIS ARRT
HCA HealthONE Aurora —Aurora, CO
- $37.26 - $55.91 an hour
- Full-time
- Adults
- Mid-level
- Adolescents
- Employee stock purchase plan
- Disability insurance
Quick Apply
9d
Probation Services Analyst I
Colorado Judicial Branch —Denver, CO
- $5,800.68 - $100,932.36 a year
- Full-time
- Writing skills
- Office
- Analysis skills
1d
Child and Family Services Administrative Reviewer
State of Colorado —Denver, CO
- $6,022 - $9,636 a month
- Online Application
- Background check
- Management
- Mid-level
- Wellness program
- Health savings account
9d
Project Coordinator
Solutions-ii —Littleton, CO
- $60,000 - $70,000 a year
- Microsoft Excel
- Mid-level
- Office
Senior Software Quality Engineer II
CesiumAstro —Westminster, CO
- $130,000 - $161,000 a year
- Full-time
- Computer Science
- Bachelor's degree
- Linux
- Health savings account
- Health insurance
Specialist II - Watkins, CO
Colorado Coalition for the Homeless —Watkins, CO
- $26.25 an hour
- Full-time
- Spanish
- Mid-level
- Children
- 403(b) matching
- AD&D insurance
Quick Apply
22h
Contractor - Manufacturing Technician II (Manufacturing Technician, 2)
Redwire Space —Littleton, CO
- $26 - $33 an hour
- Weekends as needed
- Background check
- Mid-level
- High school diploma or GED
Quick Apply
QC Incoming Inspector I-III
ESS Metron LLC —Denver, CO
- $25 - $30 an hour
- Full-time
- Engineering
- Mid-level
- High school diploma or GED
- Paid parental leave
- Health savings account
Quick Apply
2d
Research Associate/Senior Research Associate
KBI Biopharma —Boulder, CO
- $55,000 - $85,000 a year
- Full-time
- Master's degree
- Bachelor's degree
- Continuous improvement
8d
Process Development Associate II
KBI Biopharma —Boulder, CO
- $55,000 - $75,000 a year
- Full-time
- Bachelor of Science
- Mid-level
- Bachelor's degree
10d
KBI: US - Downstream Process Development Scientist II
KBI Biopharma —Boulder, CO
- $106,480 - $146,410 a year
- Full-time
- Customer service
- Bachelor of Science
- Data analysis skills

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Quality Engineer

LivaNova -
Arvada, CO

Apply Now

Job Details

Full-time
$85,000 - $95,000 a year

Qualifications

Statistics
Customer communication
Manufacturing facility experience
Math
Medical device manufacturing facility experience
Regulatory/legal compliance standards in production
Cleanroom experience
Biomedical regulatory compliance
Computer skills
Healthcare compliance
FDA regulations

Full Job Description

As a global medtech company, we are driven by our Vision of changing the trajectory of lives for a new day and our Mission to create ingenious solutions that ignite patient turnarounds. Our relentless commitment to patients and strong legacy of innovation in healthcare are the foundation of our future. If you're looking for a new chance, a new beginning, a new trajectory, LivaNova is where your talent can truly thrive. Join our talented team members worldwide to become a pioneer of tomorrow—because at LivaNova, we don’t just treat conditions — we aspire to alter the course of lives.

Position Summary:

With a high degree of autonomy, person will perform quality work of a broad nature to achieve successful outcomes of departmental and company objectives.

The Quality Engineer will contribute to ensure that production and process control activities are conducted in compliance with the company quality management system and the international regulations governing medical device manufacturing and distribution.

Evaluates situations of non-conforming products, collects and analyses data to propose product disposition and CAPA's to address quality issues. This position also analyzes product complaint returns and determines actions required to prevent recurrence or communicates the information to the manufacturer or creates process improvements.

General Responsibilities:

Supports Quality Management for executing the quality engineering activities related to the design and manufacture of the products in compliance with the Quality Management System requirements and the regulations of the countries where the franchise distributes and sells products.

Collect and critically analyze data and take disposition decisions on nonconforming products identified in production.
Lead proper investigation to identify the causes of components / product failures (nonconforming products from production and complaints)
Generate the evaluation of the risk posed by the observed NC on products already distributed (Health Hazard Evaluation) to help management determine if Stop Shipment and/or Field Action is initiated.
Lead CAPA projects and trend data to identify opportunities for future CAPA.
Whenever applicable support external manufacturers of semi-finished and finished products in the management of any detected nonconformities.
May notify suppliers of any non-conformance related to purchased material and evaluate corrective actions consistency versus internal controls.
Establishes product quality control inspections/plans
Reviews process validation planning, protocols and reports
Perform preliminary review of the change impact assessment to confirm that quality requirements are met
Establish and maintain Risk Management files
Collaborates in the investigations into the cause of V&V failures
Identify opportunities for quality improvements in the production area and lead improvement plans
Daily management of the assigned complaint handling activities.
Customer-related processes involving use of the device.
Complaint evaluations and investigations.
Provides support for timely analysis to meet Customer Quality complaint and MDR reporting quality metrics.
Leads effective meetings, conducts presentations, establishes quality records.
Develops effective relationships with internal personnel and external stakeholders to assist customers and drive the resolution of customer complaints

Skills and Experience:

Minimum related work experience of 1-3 years in Class II/III medical device manufacturing or related regulatory industry.
Knowledge of regulatory requirements (e.g., FDA, ISO 13485) as required for the position.
Experience with MDSAP and Medical Device Requirements is a plus
Must have proficiency with quality tools such as flowcharts, statistical data analysis, mathematical reasoning
Ability to analyze and problem-solve with CAPA experience
Ability to work within a changing environment.
Ability to work with a wide variety of personnel on all levels and utilize constructive confrontation
ASQ Certified Quality Engineer or other ASQ Certifications is a plus.
Excellent communication (written and verbal) and presentation skills.
Able to communicate across functional lines.
Sitting 60-80%, standing & walking 20-40%
Repetitive work on computer 80%
Oral and written comprehension
Must be able to work in a clean room environment and tolerate chemical odors.
Must be able to work in a lab environment and tolerate the smell and sight of blood.
Must be willing to take on related duties as required in support of company and departmental objectives.

Education:

Bachelor’s Degree in Technical and Scientific disciplines (Engineering, Physics, Chemistry, and Biology)

Pay Transparency: $85,000-$95,000 salary + annual bonus incentive.

Travel Requirements:

Occasional travel may be required.

Valuing different backgrounds:

LivaNova values equality and diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination. Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.

Notice to third party agencies:

Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.

Beware of Job Scams:

Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons posing as LivaNova recruiters or employees. The scammers may attempt to solicit confidential, personal information, such as a social security number, or your financial information. LivaNova will never ask for fees prior/during/after the application process, nor will we ask for banking details or personal financial information in return for the assurance of employment. If you are concerned that an offer of employment might be a scam or that the recruiter is not legitimate, please verify by searching for “See Open Jobs” on https://www.livanova.com/en-us/careers, and check that all recruitment emails come from an @livanova.com email address.

Apply Now

Refine Your Search

ii material quality assurance jobs in westminster, co

Quality Engineer

Research Associate I/II

Quality Engineer II

Lab Technician II

Quality Inspector Night Shift

Manufacturing Associate I/II

PMT II Working Zone Proctor

Category Manager II, Direct Materials (DIM)

EP Technologist

Cardiovascular Specialist RTR RCIS ARRT

Probation Services Analyst I

Child and Family Services Administrative Reviewer

Project Coordinator

Senior Software Quality Engineer II

Specialist II - Watkins, CO

Contractor - Manufacturing Technician II (Manufacturing Technician, 2)

QC Incoming Inspector I-III

Research Associate/Senior Research Associate

Process Development Associate II

KBI: US - Downstream Process Development Scientist II

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