Quality Assurance Engineer

LaunchWorks is seeking a Quality Assurance Engineer to join our team! As a Quality Assurance Engineer, you will have the opportunity to work with state-of-the-art technologies and be on the forefront of technological advancements in biotech while working closely with diverse stakeholders on multifaceted projects.

If you are ready to make a difference and build your career in a dynamic and rapidly evolving field, look no further!

If your skills, experience, and qualifications match those in this job overview, do not delay your application.

As a Quality Assurance Engineer, you will be a major part of the QA Department and will serve as the go-to for day-to-day operations / investigations under the QA Manager as well as assisting Operations with new quality-oriented projects, such as but not limited to, automation.

The Quality Engineer will lead, monitor, and track the validation and equipment qualification process. The Quality Engineer will assist the organization in equipment and process qualification efforts as well as the QA Lead for management of this equipment.

Assist QA in verification, validation, and risk analysis efforts. Perform other assorted clerical and investigatory tasks in the QA department as needed.

Assist Operations in planning and performing studies involving scientific measurement, data collection, and statistical analysis to qualify and / or determine the suitability of measurement systems as deemed necessary (Quality Plans).

Participates in internal, customer and regulatory audits as appropriate. Will be the Subject Matter Expert in equipment validation and qualification.

Key Responsibilities :

• Equipment & process qualifications.
• Work closely with operations, sales, and development to evaluate potential new projects requiring new processes, equipment, and taking the lead in validating and qualifying those processes / equipment to ensure a timely implementation.
• Collaborate effectively with vendors, clients, and internal stakeholders to reach project goals.
• Review QMS procedures for suitability and identify opportunities for improvement.
• Apply standards and regulations relevant to Quality Management System (QMS).
• Perform studies involving scientific measurement, data collection, and statistical analysis to qualify and / or determine the suitability of measurement systems as deemed necessary (Quality Plans).
• Oversee the verification, validation, and risk analysis process.
• Participate in audits.
• Assist with other QA tasks as needed.

WHAT YOU NEED TO SUCCEED (Minimum Qualifications) :

Bachelor's Degree in Engineering, Life Sciences, Chemistry, Biology, Molecular Biology, Biochemistry, Mechanical Engineering or commensurate experience.

MS preferred but not required.

• 1-2 years of quality engineering experience in a lab environment.
• At least 1-2 years’ experience working in a regulated industry.
• Proficiency in Microsoft Office, ERP, QMS.

WHAT WILL SET YOU APART (Competencies)

• Strong attention to detail and organizational skills.
• Strong communication skills and command of the English language.
• Strong writing and documentation skills.
• Ability to seek knowledge from outside sources when necessary and apply it critically and comprehensively to ongoing projects.
• Positive external and internal relationship management skills.
• Ability to work collaboratively as part of a team to ensure that demanding projects are handled smoothly and cooperatively.
• Proven ability to thrive in a change-oriented environment.
• Confidence in working with quality assurance, quality control, and Quality Management Systems (ISO 9001 or ISO 13485).

It is LaunchWorks policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.

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