Quality Assurance Engineering Manager jobs in Cedar Rapids, IA
Quality Assurance Engineering Manager manages inspections of raw materials, equipment, processes, and finished products. Implements quality standards and protocols for quality assurance testing models. Being a Quality Assurance Engineering Manager assists in the design and implementation of policies and procedures for testing and evaluating the precision and accuracy of products and/or equipment. Ensures projects are completed on time and within budget. Additionally, Quality Assurance Engineering Manager acts as a technical advisor to quality assurance engineering team regarding projects, tasks, and operations. Requires a bachelor's degree. Typically reports to a head of a unit/department. The Quality Assurance Engineering Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Quality Assurance Engineering Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)
Recently Added Quality Assurance Engineering Manager jobs
Radiopharmaceutical Quality Assurance Manager
- Perspective Therapeutics
-
Coralville, IA
FULL_TIME
-
Objective
The Manager, Quality Assurance helps ensure the consistent production of safe, effective, and high-quality radiopharmaceutical products that meet regulatory requirements and industry standards at the site level. This involves overseeing all aspects of quality assurance throughout the manufacturing process in alignment with company objectives, including testing, documentation, and compliance with Good Manufacturing Practices (GMP) and other relevant regulations. Additionally, the Manager is responsible for implementing quality improvement initiatives, training staff, and facilitating communication between different departments to maintain and enhance the overall quality management system.
Essential Functions
- Directs the day-to-day activities of the Quality Assurance team at the designated facility.
- Communicates aligned quality objectives and requirements to company management and co-workers with a goal to foster a company-wide culture of quality focus and compliance.
- Manages and executes a quality management program consistent with pharmaceutical manufacturer requirements for API starting material and finished drug products.
- Executes and enhances quality aspects of project-specific plans to support company goals.
- Participates in company initiatives to apply quality principles to procedures and standards.
- Reviews design specifications, procedures, and other technical documents to ensure GXP alignment with GXP requirements.
- Oversees Change Control for TPI processes subject to quality requirements.
- Develops personnel training related to quality and good manufacturing practices.
- Oversees implementation and training of the Quality Management System (QMS).
- Oversees batch record approval process and acts as responsible manager ensuring quality attributes of batch.
- Manages the audit program, including regular internal audits and a supplier audit program. Directs the resolution of findings and ensures proper follow-up.
- Signatory to Quality Agreements associated with Supply Agreements.
- Manages Corrective and Preventive Action (CAPA) program, Continuous Improvement initiatives, Risk Management, and Out-of-Specification Investigations.
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education / Experience
- Bachelor's Degree in a science, health, or related field (extensive equivalent QA experience in a pharmaceutical discipline may be considered as a substitute for academic degree).
- At least 7 years of progressive experience in GxP, QA management or QA positions in a Pharmaceutical and/or Medical Device industry is required.
- Experience with manufacture of sterile products, with aseptic expertise preferred.
- In-depth knowledge of radiopharmaceutical manufacturing processes is preferred, with a proven track record of implementing and maintaining robust quality management systems.
- Experience in compliance with Current Good Manufacturing Practices for pharmaceuticals and FDA Part 210/211 is required, and experience with Good Clinical Practices preferred.
- Must have experience with CAPA, Root Cause Analysis, Continuous Improvement, and OOS investigations.
Knowledge / Skill / AbilityFor information on Perspective Therapeutics, visit our website at: www.perspectivetherapeutics.com.
- Understand the principles of radiation safety and apply worker safety considerations to procedures, with the guidance of Perspective radiation safety experts.
- Understanding of sterile drug manufacturing requirements.
- Must have keen attention to detail with the ability to read and interpret regulatory requirements and industry standards and apply information to quality standards.
- Excellent written, verbal and interpersonal communication skills, with proven ability to collaborate, communicate and manage well at all levels of the organization.
- Demonstrated ability to work independently, manage projects and lead change across the organization.
- Ability to focus on critical issues and balance and respond to competing short-term and long-term priorities.
- commitment to continuous improvement to drive excellence in aseptic, radiopharmaceutical quality assurance practices.
- Commitment to continuous improvement to drive excellence in aseptic radiopharmaceutical quality assurance practices.
- Ability to facilitate meetings and discussions in person and virtually.
- Ability to travel up to 30%.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Must be willing to work in a facility producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
- Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.
- May be required to sit or stand for long periods of 8 hours a day while performing duties.
- Occasional kneeling, crouching, twisting the upper body, bending, stooping, pushing, pulling, or reaching may be required.
- Must possess good hand-eye coordination; close attention to detail is required.
- Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including radioactive, corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
- Must be willing to wear a variety of Personal Protective Equipment (PPE), including eye and hearing protection, as needed.
- Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Perspective Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
- 19 Days Ago
MANAGER, QUALITY ASSURANCE
- Crown Holdings
-
Dubuque, IA
FULL_TIME
- Job Accountabilities CROWN Cork & Seal USA, Inc., a wholly owned company of Crown Holdings, Inc. is a global leader in the design, manufacture and sale of packaging products for consumer goods. At Cro...
- 22 Days Ago
Quality Assurance Manager
- Procter & Gamble
-
Iowa, IA
FULL_TIME
- Job Location Cincinnati Job Description Job Description P&G is the largest consumer packaged goods company in the world. We have operations in over 75 countries, with 65 trusted brands that improve li...
- Just Posted
Quality Assurance Manager
- Impact Solutions Inc
-
Decorah, IA
FULL_TIME
- Job Title: Quality Assurance Manager Location: Decorah, Iowa Salary: $80-100K Job Summary of the Quality Assurance Manager: The Quality Assurance Manager is a member of the Processing Management Team,...
- 1 Month Ago
Quality Assurance Specialist I
- Perspective Therapeutics
-
Coralville, IA
FULL_TIME
- ObjectiveThe Quality Assurance Specialist I will support the design, implementation and maintenance of QA and compliance programs including, but not limited to an SOP system and corrective action and ...
- 18 Days Ago
Quality Assurance Inspector
- Berry Global, Inc
-
PEOSTA, IA
FULL_TIME
- Overview About BerryHarnessing the strength in our diversity and industry-leading talent of 40,000 employees across more than 250 global locations, we develop, design, and manufacture innovative produ...
- 1 Day Ago
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0 Quality Assurance Engineering Manager jobs found in Cedar Rapids, IA area
Quality Assurance Manager
- Sedona Staffing Services
-
Manchester, IA
- QUALITY MANAGER DIRECT HIRE-NE IOWA SALARY: 80K-95K/YEAR Responsibilities Provide day to day quality support to manufact...
- 4/25/2024 12:00:00 AM
Senior Process Engineer
- Exide Technologies
-
Manchester, IA
- Overview Senior Process Engineers are focused on helping the Company achieve its mission - to be the quality leader in t...
- 4/25/2024 12:00:00 AM
Resource Planning Analyst
- Central Iowa Power Cooperative
-
Cedar Rapids, IA
- Central Iowa Power Cooperative (CIPCO) is currently searching for a Resource Planning Analyst to join the team in Cedar ...
- 4/25/2024 12:00:00 AM
Repair and Production Technician
- Gatso Usa Inc
-
Marion, IA
- Job Description Job Description About Sensys Gatso Sensys Gatso USA, part of the Sensys Gatso Group in Sweden, is celebr...
- 4/24/2024 12:00:00 AM
Manufacturing (Process) Engineer
- Crown Cork & Seal Usa Inc.
-
Cedar Rapids, IA
- CROWN Cork & Seal USA, Inc., a wholly owned company of Crown Holdings, Inc. is a global leader in the design, manufactur...
- 4/24/2024 12:00:00 AM
Principal Quality Engineer, Engineering Quality (Onsite)
- Raytheon Technologies
-
Cedar Rapids, IA
- Date Posted: 2024-04-19 Country: United States of America Location: HIA32: Cedar Rapids, IA 400 Collins Rd NE , Cedar Ra...
- 4/24/2024 12:00:00 AM
Quality Assurance Manager
- Sedona Staffing Services
-
Manchester, IA
- QUALITY MANAGER DIRECT HIRE-NE IOWA SALARY: 80K-95K/YEAR Responsibilities • Provide day to day quality support to manufa...
- 4/24/2024 12:00:00 AM
Manufacturing Process Engineer, Iowa City Beauty Care
- Procter & Gamble Company
-
Iowa City, IA
- Job Location Iowa City Job Description P&G is the largest consumer packaged goods company in the world. We have operatio...
- 4/22/2024 12:00:00 AM
About Cedar Rapids, Iowa
The city is divided into four quadrants, used in addressing. 1st Avenue (U.S. Route 151 Business) divides the north and south sides of the city, and the Cedar River divides east and west. Mays Island, in the middle of the river, is the only area of the city where addresses have no quadrant. Areas outside the city limits that have a Cedar Rapids mailing address do not use the quadrants either.
Except in the downtown area, 1st Avenue and the Cedar River tend to run diagonally instead of along the cardinal directions. Due to the curving of 1st Avenue, there are some areas in western Cedar Rapids ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Quality Assurance Engineering Manager jobs
$120,615 to $149,886
Cedar Rapids, Iowa area prices
were up 0.8% from a year ago
were up 0.8% from a year ago
What does a Quality Assurance Engineering Manager do?
Quality Assurance Engineering Manager in Ogden, UT
Industrial production managers are responsible for carrying out quality control programs to make sure the finished product meets a specific level of quality.
December 31, 2019
Quality Assurance Engineering Manager in Pittsfield, MA
Establishing best-practices, provide input to quality standards, looking for continuous improvement initiatives and help the team grow as they pursue initiation of an Automation Strategy.
December 21, 2019
Quality Assurance Engineering Manager in Long Beach, CA
Help define automation framework to accelerate testing with the highest levels of quality and accuracy.
January 31, 2020