Top 126 Quality assurance Jobs in Birmingham, Al

Senior Quality Engineer
FloodGate Medical —Birmingham, AL
- $116,000 - $120,000 a year
- Overtime
- 5 years
- Bachelor of Science
- Data analysis skills
- Health insurance
- Dental insurance
Quick Apply
10d
Mortgage Risk Quality Control Specialist
Regions —Hoover, AL
- $50,500 - $63,650 a year
- Overtime
- Microsoft Excel
- Microsoft Outlook
- Data analysis skills
- Health savings account
- Health insurance
Automation Testing Engineer
Vaco by Highspring —Birmingham, AL
- $130,000 - $160,000 a year
- System design
- HIPAA
- Analysis skills
- Health insurance
- Dental insurance
Quick Apply
9d
Quality Assurance Supervisor
Magna International —Birmingham, AL
- Extended hours
- Microsoft Excel
- Ability to walk for extended periods
- Engineering
Quick Apply
QA Analyst
AutoTec —Birmingham, AL
- Computer literacy
- Mid-level
- Associate's degree
Quick Apply
Commercial Credit Products Quality Assurance and Improvement Analyst
Regions —Hoover, AL
- $67,878.20 - $85,281.00 a year
- Full-time
- Research
- Mid-level
- Office
- Health savings account
- Health insurance
Quality Inspector
Birmingham Fastener & Supply —Birmingham, AL
- Full-time
- Microsoft Outlook
- Mid-level
- High school diploma or GED
Quality Assurance Inspector - Printed and Packaging Components
Oxford Pharmaceuticals, LLC —Birmingham, AL
- $17 - $18 an hour
- Full-time
- Background check
- Microsoft Outlook
- Computer literacy
- Health insurance
- Dental insurance
Quick Apply
Pharmaceutical Lab Technician - BIRMINGHAM, AL
Siemens Healthineers —Birmingham, AL
- $40,030 - $55,044 a year
- Overtime
- Customer service
- Word processing
- Computer literacy
- Paid training
- Disability insurance
QA Software Analyst
PharmaPoint —Birmingham, AL
- $76,000 - $117,000 a year
- Full-time
- Hybrid work
- Computer Science
- Mid-level
- Java
- Dental insurance
- 401(k)
Quick Apply
13d
Quality Assurance Engineer
HEALTHPLANONE, LLC —Birmingham, AL
- Full-time
- Computer science
- Computer Science
- Writing skills
- Health insurance
Quick Apply
Quality Trainee - PM Shift
Milo's Tea Company Inc —Bessemer, AL
- Overtime
- Trade school
- Associate's degree
- Entry level
- Tuition reimbursement
- Parental leave
3d
Quality Supervisor
Atlas Tube (Alabama) INC —Birmingham, AL
- Full-time
- Customer service
- Ability to walk for extended periods
- 5 years
- Profit sharing
- Paid holidays
Quick Apply
Quality Inspector
BIOHORIZONS IMPLANT SYSTEMS —Hoover, AL
- Full-time
- Computer literacy
- Writing skills
- Pass drug screening
- Paid parental leave
- Health savings account
Quick Apply
6d
QA Clerk
Ventura Foods —Birmingham, AL
- 8 hour shift
- Microsoft Excel
- Writing skills
- Sanitation
- Profit sharing
- Paid holidays
Reagent QC Associate I
BioGX Inc —Birmingham, AL
- $38,000 - $42,000 a year
- Full-time
- Microsoft Word
- Microsoft Excel
- Computer literacy
Quick Apply
Quality Assurance Technician
HarbisonWalker International —Fairfield, AL
- Computer literacy
- Basic math
- Mid-level
Temporary Quality Assurance Specialist
HEALTHPLANONE, LLC —Birmingham, AL
- Full-time
- Spanish
- Microsoft Outlook
- Writing skills
- Health insurance
Quick Apply
5d
Quality Assurance Tester
SPOC Energy —Trussville, AL
- Extended hours
- Mid-level
- Mentoring
- Ability to stand for extended periods
Quick Apply
Quality Assurance Supervisor - PM Shift
Milo's Tea Company Inc —Bessemer, AL
- Full-time
- Bachelor of Science
- Mid-level
- Bachelor's degree
- Tuition reimbursement
- Parental leave

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Senior Quality Engineer

FloodGate Medical
Birmingham, AL

Quick Apply

Job Details

Full-time
$116,000 - $120,000 a year
10 days ago

Benefits

Health insurance
Dental insurance
401(k)
Paid time off
Vision insurance
401(k) matching

Qualifications

Bachelor of Science
Corrective and preventive actions (CAPA)
Manufacturing facility experience
Production validation processes
Bachelor's degree
Medical device manufacturing facility experience
Attention to detail
Regulatory/legal compliance standards in production
Design controls
Biomedical regulatory compliance
Process management
ISO 13485
FDA regulations

Full Job Description

JOB OVERVIEW:
As a Senior Quality Engineer, you will assist with the development of quality systems, procedures and controls to ensure that all medical products consistently meet performance and quality specifications in the manufacturing facility. The Senior Quality Engineer is a leader and strong technical resource who quickly and effectively resolves quality problems with internal customers and external suppliers. This position reports directly to the Director of Quality Assurance/Regulatory Affairs. The Senior Quality Engineer will play a key role in supporting existing manufacturing processes for the company's medical device product line.

JOB RESPONSIBILITIES AND DUTIES:

Consistently models the core values of the company both internally and externally.
Openly commits to and supports company processes and systems.
Revises/analyzes whether current products and processes (including actions or decisions taken) comply with regulations such as QSRs, ISO 13485, etc., including providing support during internal and external audits.
Participates in preparation activities for, or interactions with, regulatory agencies (e.g., FDA, notified bodies).
Actively participates in Management Review & Compliance meetings.
Responds to internal or external audit observations related to the quality engineering function.
Properly establishes and maintains required documentation of quality assurance activities and/or quality systems.
Supervises and supports quality assurance personnel on daily activities.
Performs periodic line audits to evaluate GMPs, production controls, lot segregation, and process audits. Checks audit results to ensure corrective and preventive actions are adequate.
Acts as the QA representative for Supplier Quality management activities. Responsible for maintaining supplier controls and performing supplier auditing activities.
Acts as the QA representative on design projects supporting new product introductions, qualification of new suppliers, and development/approval of new product documentation.
Works with NPI, manufacturing, process engineering, and manufacturing engineering departments to develop, conduct, and approve product and process validation strategies.
Directs and attends NCR meetings as a member of MRB.
Conducts and supports investigations, bounding, documentation, revision, and approval of non-conformities (NCs), preventive and corrective actions (CAPAs), and customer complaints. Escalates quality problems when applicable.
Acts as delegate for the Quality Director when required.
Champions continuous improvement through the CAPA system, complaint handling, and KPI analysis.
Provides support in analyzing products related to customer complaints to determine failure modes.
Analyzes/checks the effectiveness of preventive and corrective actions.
Defines sampling plans and approves inspection methods for evaluation and acceptance of components and finished product.
Provides support in resolving complex technical problems associated with the manufacturing process.
Revises, approves, and executes IQ, OQ, and PQ validations.
Maintains and periodically revises CTQs in the manufacturing process to ensure continuous customer satisfaction.
Develops, maintains, and checks that measuring methods are appropriate for manufacturing processes.
Provides support in revising and maintaining FMEAs, quality control plans, process instructions, and other manufacturing documents.
Develops, interprets, and properly implements process monitoring and control methods consistent with process/product risk level.
Evaluates and interprets common vs. special cause variation in the manufacturing process and determines the adequacy of current process limits.
Evaluates the need for risk mitigation techniques given product classification, defect types/frequency/severity, patient risk, process capacity, and process controls; determines the effectiveness of previously implemented improvements.
Owns the risk assessment process, including realization, documentation, revision, and maintenance of risk assessments (e.g., FMEA) as products/processes change.
Collates and trends key performance indicator data.
Performs other related duties as assigned to support efficient organizational operation.
Carries out additional responsibilities and tasks assigned by management.

Key Metrics: CAPAs, NCRs, SCARs

QUALIFICATIONS / EDUCATION AND EXPERIENCE:

BS degree in manufacturing engineering, quality engineering, life science, or related field, and a minimum of 5 years of experience within the medical device industry.
Highly motivated with excellent communication skills and proven ability to work as part of a team.
Familiarity with Quality System Requirements (QSR), Gage R&R, ISO 13485, IQ/OQ/PQ, CTQ, Production NC, CAPA, regulatory requirements, Verification & Validation, medical device engineering change process, medical device quality management, design controls, and problem-solving methods.
Quality Certification and/or Lead Auditor Certification are not mandatory but would be an advantage.

KNOWLEDGE, SKILLS AND ABILITIES:

Strong written and verbal communication.
Organizational skills.
Ability to summarize complex issues quickly and make decisions.
Ability to work under pressure and plan personal workload effectively to prioritize appropriately.

PHYSICAL ACTIVITIES:

Body Positions: Regularly required sitting, standing, and walking for prolonged periods.
Body Movements: Full range of body movements, including use of hands/fingers to handle or feel objects, and bending, reaching, lifting, and crouching.
Vision: Ability to read and see instructions and computer screens.

MENTAL REQUIREMENTS:

Attention to Detail: Able to focus on small details and ensure accuracy and precision.
Relational: Able to comfortably connect and work with different personalities inside and outside the company.
Communication Skills: Able to read and write clearly to communicate effectively with team members and supervisors.

WORKING CONDITIONS:

Work is generally performed in an office and manufacturing environment.
May require occasional early morning or late afternoon meetings to support business needs.
Travel may be required for meetings, training events, conferences, or team meetings, including occasional overnight or weekend travel, domestic and international.
Extended computer and presentation time.
Work Hours: Full-time, standard working hours, typically Monday through Friday. Occasional overtime or weekend work may be required to meet deadlines.
Health and Safety: Strict adherence to health and safety guidelines is required to prevent accidents and ensure a safe working environment. Regular training on safety procedures and emergency protocols is provided.

Pay: $116,000.00 - $120,000.00 per year

Benefits:

401(k)
401(k) matching
Dental insurance
Health insurance
Paid time off
Vision insurance

Work Location: In person

Quick Apply

Refine Your Search

quality assurance jobs in birmingham, al

Senior Quality Engineer

Mortgage Risk Quality Control Specialist

Automation Testing Engineer

Quality Assurance Supervisor

QA Analyst

Commercial Credit Products Quality Assurance and Improvement Analyst

Quality Inspector

Quality Assurance Inspector - Printed and Packaging Components

Pharmaceutical Lab Technician - BIRMINGHAM, AL

QA Software Analyst

Quality Assurance Engineer

Quality Trainee - PM Shift

Quality Supervisor

Quality Inspector

QA Clerk

Reagent QC Associate I

Quality Assurance Technician

Temporary Quality Assurance Specialist

Quality Assurance Tester

Quality Assurance Supervisor - PM Shift

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