QA Engineering Manager
Job Posting for QA Engineering Manager at OriGen Biomedical
OriGen Biomedical is a global leader in cryopreservation and cell culture. We collaborate with top researchers, clinicians and business partners to enhance solutions, improve patient outcomes, and achieve customer satisfaction by providing safe and effective products that positively impact the quality of life.
POSITION SUMMARY
The QA Engineering Manager is responsible for all quality system and product quality activities for OriGen Biomedical, including ensuring compliance to global quality system regulations and standards such as 21 CFR 820, ISO 13485:2016 and MDSAP. This position oversees the quality team and manages the daily activities associated with releasing high quality products under a compliant quality management system.
The QA Engineering Manager is responsible for all quality system and product quality activities for OriGen Biomedical, including ensuring compliance to global quality system regulations and standards such as 21 CFR 820, ISO 13485:2016 and MDSAP. This position oversees the quality team and manages the daily activities associated with releasing high quality products under a compliant quality management system.
ESSENTIAL DUTIES AND RESPONSIBILITIES
The essential duties and responsibilities of this position include, but are not limited to the following:
- Leads a team of quality personnel, including specialists, and engineers, acting as a mentor and facilitating effective communication and workload/priority management
- Ensure effectiveness of the quality management system, including planning, managing and executing quality policies, procedures, and programs
- Identify and guide areas of QMS improvement and enhancement to meet both the needs of the organization and any new or changing regulatory requirements
- Coordinate internal and external quality system audits, including those from regulatory authorities, notified bodies, and customers
- Manage the complaint and CAPA processes, including efficient resolution of complaints and implementation of appropriate corrective and preventive actions to correct or prevent deficiencies
- Carry out vendor qualification and act as primary contact for customers wanting to qualify OriGen as a vendor
SUPERVISORY RESPONSIBILITY
- Supervises department of 4 and growing
- Develops and optimizes department schedules
- Maintains training of current QA staff
- Recruits and trains new QA personnel
- Works closely with other supervisory personnel
COMPETENCIES
• Building Relationships: proven leadership, including ability to motivate, teach/mentor and delegate • Teamwork - build a team and be a member of the team • Demonstrated interpersonal skills, including ability to work cross-functionally to achieve business goals • Conflict Resolution
MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, AND ABILITIES)
- Effective communication skills (verbal and written)
MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, AND ABILITIES)
- Bachelor’s degree in Science, or equivalent
- 6 years professional work experience Quality Assurance
- 2 years direct supervisory/ leadership experience
- Quality Systems knowledge in a regulated environment, including subject matter expert knowledge in 21 CFR 820 and ISO 13485:2016
PREFERRED QUALIFICATIONS
- Experience with both quality system and quality engineering/ product quality
- Experience and sound knowledge in MDSAP requirements and audits
- Experience working in a manufacturing environment with ISO-qualified cleanrooms
Work Environment
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
This job periodically operates in a cleanroom environment. Cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom coat, bouffant, face mask, and gloves.
Position Type and Expected Hours of Work
This is a full-time position required to work onsite.
Days and hours of work are typically Monday through Friday, 8:30 a.m. to 5 p.m. In some cases, additional work hours may be required. 5-10% travel as needed.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.
While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus. The noise level in the office environment is usually minimal.
NOTE
This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an “at will” relationship.
OriGen Biomedical is an Equal Opportunity Employer and complies with all Federal, State, and Local employment laws, including ADA.
QA Manager
Intertek US -
Austin, TX
Senior Software QA Engineer Apple Services Engineering.
Apple -
Austin, TX
QA/Test Manager
Amer Technology, Inc -
Austin, TX
Salary.com Estimation for QA Engineering Manager in Austin, TX
$144,817 to $180,271
If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution.
Compensation Planning
Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right.
Surveys & Data Sets
Sign up to receive alerts about other jobs with skills like those required for the QA Engineering Manager.
Click the checkbox next to the jobs that you are interested in.
-
Computer Simulation Skill
-
Income Estimation: $159,109 - $199,979
-
Income Estimation: $156,198 - $194,449
-
-
Cost Estimation Skill
-
Income Estimation: $150,095 - $198,137
-
Income Estimation: $156,198 - $194,449
-
This job has expired.
View Core, Job Family, and Industry Job Skills and Competency Data for more than 15,000 Job Titles
Skills Library
Job openings at OriGen Biomedical
OriGen Biomedical
Austin, TX
Full Time
OriGen Biomedical
Austin, TX
Full Time
Not the job you're looking for? Here are some other QA Engineering Manager jobs in the Austin, TX area that may be a better fit.
We don't have any other QA Engineering Manager jobs in the Austin, TX area right now.
QA Test Analyst I - Qualitest, Austin, TX
Sanmina Corporation, Austin, TX