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.

Equipment & process qualifications.
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
effectively with vendors, clients, and internal stakeholders to reach project goals.
QMS procedures for suitability and to identify opportunities for improvement.
and application of standards and regulations relevant to Quality Management System (QMS).
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).
the verification, validation and risk analysis process.
in audits.
for other QA tasks as needed.

WHAT YOU NEED TO SUCCEED (Minimum Qualifications):

Bachelors 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
Microsoft Office, ERP, QMS

WHAT WILL SET YOU APART (Competencies)

Strong attention to detail and organizational skills.
Strong communication skills and command of English language.
Strong writing and documentation skills.
Proficiency to seek knowledge from outside sources when necessary and to apply it critically and comprehensively to ongoing projects.
Positive external and internal relationship management skills
Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively, to enhance the success of such projects, and to maintain strong relationships within all parts of the company
Proven ability to thrive in a change-oriented environment
Confident working in 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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Quality Assurance Engineer