Quality Control Bioengineer Job Description [Updated for 2025]

In the realm of biotechnology, the critical role of quality control bioengineers is increasingly recognized.

As biotech advances, the demand for proficient individuals who can design, monitor, and maintain the quality control processes within the bioengineering sector grows more pressing.

But let’s delve deeper: What’s truly expected from a quality control bioengineer?

Whether you are:

• A job seeker looking to understand the core of this role,
• A hiring manager outlining the perfect candidate,
• Or simply fascinated by the complexities of quality control in bioengineering,

You’ve come to the right place.

Today, we present a customizable quality control bioengineer job description template, designed for effortless posting on job boards or career sites.

Let’s dive right in.

Quality Control Bioengineer Duties and Responsibilities

Quality Control Bioengineers combine their knowledge of engineering principles with their understanding of biology and biotechnology.

They ensure that all processes and products in the life sciences meet the highest standards of quality and safety.

Their duties and responsibilities include:

• Evaluating and inspecting biotechnological products and processes
• Developing and implementing quality control methodologies to ensure compliance with quality assurance standards and guidelines
• Conducting risk assessments for the potential release of biotechnological products
• Compiling data for documentation needed for the testing procedures
• Performing validation and testing of new products and improvements to existing ones
• Collaborating with research and development teams to ensure the quality of new products
• Developing and implementing quality control systems to ensure product consistency and safety
• Documenting all inspection results by completing reports and logs, summarizing re-work and waste, and inputting data into quality database
• Identifying training needs and organizing training interventions to meet quality standards
• Working with regulatory bodies to ensure compliance with mandatory standards

 

Quality Control Bioengineer Job Description Template

Job Brief

We are looking for a detail-oriented Quality Control Bioengineer to join our team.

The Quality Control Bioengineer will be responsible for ensuring all products and procedures adhere to quality standards and regulations.

Responsibilities include conducting tests, identifying and analyzing issues, implementing corrective actions, and ensuring that all quality records are maintained properly.

The ideal candidate should be highly analytical, have a keen eye for detail and possess a strong understanding of bioengineering principles and quality control methodologies.

 

Responsibilities

• Conducting routine and non-routine analyses of samples using validated methods
• Performing quality control tests in the lab as well as on-site when necessary
• Inspecting and testing material, equipment, and products to ensure adherence to established standards
• Developing and executing test plans to ensure product quality
• Creating and maintaining documentation, such as quality assurance protocols
• Investigating and troubleshooting product quality issues
• Providing technical support and advice on quality control issues
• Preparing reports on all activities and findings
• Following and ensuring compliance with quality system protocols

 

Qualifications

• Proven work experience as a Quality Control Bioengineer or similar role
• Knowledge of quality control standards and methodologies
• Hands-on experience with Quality Management Systems (QMS) and testing methodologies
• In-depth understanding of bioengineering principles
• Familiarity with regulatory and compliance procedures
• Strong analytical and problem-solving skills
• Excellent written and verbal communication skills
• BSc degree in Bioengineering, Quality Assurance or relevant field

 

Benefits

• 401(k)
• Health insurance
• Dental insurance
• Retirement plan
• Paid time off
• Professional development opportunities

 

Additional Information

• Job Title: Quality Control Bioengineer
• Work Environment: Laboratory setting. Some travel may be required for on-site testing or meetings.
• Reporting Structure: Reports to the Quality Control Manager.
• Salary: Salary is based upon candidate experience and qualifications, as well as market and business considerations.
• Pay Range: $75,000 minimum to $130,000 maximum
• Location: [City, State] (specify the location or indicate if remote)
• Employment Type: Full-time
• Equal Opportunity Statement: We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
• Application Instructions: Please submit your resume and a cover letter outlining your qualifications and experience to [email address or application portal].

 

What Does a Quality Control Bioengineer Do?

Quality Control Bioengineers usually work in industries such as pharmaceuticals, biotechnology, and medical devices.

They can also be found in research institutions and government agencies.

Their primary role is to ensure that the biological products, processes, and procedures adhere to defined quality standards.

They do this by designing, implementing, and maintaining quality control systems.

They conduct routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples.

They also interpret test results, compare them to established specifications and control limits, and make recommendations on the appropriateness of data for release.

Quality Control Bioengineers are responsible for investigating and troubleshooting product or production issues and for developing solutions.

They also ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

Moreover, they also review and update standard operating procedures or quality assurance manuals and collaborate with other engineers or teams to ensure consistent application of quality control processes.

Additionally, they may also be tasked with the evaluation of new testing and sampling methodologies or technologies and with training and overseeing junior staff and technicians.

 

Quality Control Bioengineer Qualifications and Skills

Quality Control Bioengineers use a blend of technical skills, scientific knowledge and attention to detail to ensure that biotechnological products and processes meet the required standards and regulations.

The qualifications and skills needed include:

• Strong knowledge of biology, chemistry, and engineering principles to understand the science behind the products and processes they are evaluating.
• Technical proficiency in utilizing laboratory and scientific equipment, as well as computer software for data analysis and reporting.
• Strong analytical and problem-solving skills to identify and resolve issues that can affect the quality of products or processes.
• Excellent attention to detail to ensure that all elements of the production process meet the required quality standards.
• Good interpersonal and communication skills to effectively work with other team members and to communicate findings and recommendations.
• A good understanding of regulatory requirements in the biotechnology field to ensure compliance.
• Physical stamina and precision to handle laboratory tasks and procedures.

 

Quality Control Bioengineer Experience Requirements

Bioengineers aiming to work in Quality Control typically need a bachelor’s degree in bioengineering or a related field.

This degree program offers the foundational knowledge necessary and provides students with practical experience through lab work and internships.

For entry-level roles, the experience required may be obtained through internships or cooperative engineering programs conducted during college.

This often involves working under supervision in a laboratory or manufacturing setting, where they gain experience in quality control testing and inspection methods.

Quality Control Bioengineers with more than 2-3 years of experience usually have a deeper understanding of biological systems, biomedical device development, and validation procedures.

They may also have experience in preparing reports on quality control activities.

Professionals with over 5 years of experience often have been involved in comprehensive quality control projects and have demonstrated expertise in the application of quality control principles.

They may also have some leadership or managerial experience, indicating their readiness for a supervisory position.

Certain roles may require advanced degrees or certifications, such as a Professional Engineer (PE) license, especially for senior or specialized roles.

Continuing education and on-the-job training are also important as technology and regulations in the bioengineering field continue to evolve.

 

Quality Control Bioengineer Education and Training Requirements

Quality Control Bioengineers typically hold a bachelor’s degree in bioengineering, biomedical engineering, or a related field.

Their degree programs will include a strong emphasis on biology, chemistry, physics, and mathematics, along with extensive laboratory work.

In addition to their degrees, Quality Control Bioengineers often acquire practical experience through internships or cooperative programs during their college years.

For certain roles or to gain advancement, a master’s degree or Ph.D. in bioengineering or a related discipline may be required.

These advanced degrees usually focus on a specific area of bioengineering and involve research projects.

Furthermore, some employers may require bioengineers to have a license, especially if they are offering their services directly to the public.

Licensure typically requires a degree from an accredited engineering program, a passing score on the Fundamentals of Engineering (FE) exam, and a passing score on the Professional Engineering (PE) exam.

Continuing education is also crucial in this field as technology and scientific knowledge continually evolve.

This can be done through professional development courses, workshops, and seminars.

Additionally, certification from a professional body, such as the American Society for Quality (ASQ), can be beneficial.

It provides proof of competence and commitment to quality control and can lead to greater job opportunities.

 

Quality Control Bioengineer Salary Expectations

A Quality Control Bioengineer earns an average salary of $74,720 (USD) per year.

However, this wage can fluctuate based on factors such as experience, educational background, geographical location, and the specific industry of employment.

 

Quality Control Bioengineer Job Description FAQs

What qualifications does a Quality Control Bioengineer need?

Quality Control Bioengineers typically need a bachelor’s degree in bioengineering, biomedical engineering, or a related field.

Some positions may require a master’s degree or Ph.D. Additionally, they need experience working in a laboratory environment and knowledge of Good Manufacturing Practices (GMP).

Certifications in quality control or quality assurance are also desirable.

 

What skills are important for a Quality Control Bioengineer?

Quality Control Bioengineers should have strong analytical skills to identify and resolve quality-related issues.

They also need excellent attention to detail to ensure products meet the highest quality standards.

Other important skills include problem-solving abilities, proficiency in statistical analysis, and strong written and verbal communication skills.

 

What are the daily duties of a Quality Control Bioengineer?

Quality Control Bioengineers typically start their day by reviewing the tasks for the day, which may include testing product samples, analyzing data, or investigating any quality issues reported.

They may spend their day conducting tests and experiments, documenting results, and reviewing manufacturing processes.

They often work closely with other bioengineers and quality assurance team members to ensure that all products meet quality standards and regulatory requirements.

 

What characteristics make a good Quality Control Bioengineer?

A good Quality Control Bioengineer is meticulous and detail-oriented, ensuring that all aspects of quality control are thoroughly addressed.

They should have a strong scientific and technical acumen, and keep updated with the latest technologies and advancements in their field.

They should also have the ability to work well under pressure, and have excellent problem-solving and decision-making abilities.

 

Is it hard to find qualified Quality Control Bioengineers?

Finding Quality Control Bioengineers with the right set of skills and experiences can be challenging as it is a specialized field.

Employers often look for candidates with a strong understanding of bioengineering principles, quality control processes, and regulatory standards, which may limit the pool of qualified applicants.

However, offering competitive salaries, professional development opportunities, and a positive work environment can attract top talent in this field.

 

Conclusion

And that wraps it up.

Today, we’ve delved deep into what it truly entails to be a quality control bioengineer.

And guess what?

It’s not just about testing samples.

It’s about shaping the future of biotechnology, one quality check at a time.

With our handy quality control bioengineer job description template and real-world examples, you’re well-prepared to take the leap.

But why hold back?

Explore further with our job description generator. It’s your next course of action for meticulously crafted listings or refining your resume to the tee.

Remember:

Every test, every check, contributes to the larger scheme of things.

Let’s shape that future. Together.

How to Become a Quality Control Bioengineer (Complete Guide)

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