ABOUT OUR COMPANY: As a contract development and manufacturing organization, LaunchWorks drives advancements in diagnostic life science tools available to scientists, doctors, and patients. The company develops and manufactures products consistently, exactly, and reliably to client specifications while meeting applicable quality and regulatory requirements. We believe in supporting our customers’ development and manufacturing needs so that they can focus on their science. 

Our people are their greatest asset. They are a winning team of innovative, passionate, and knowledgeable experts with a track record of turning complex life science ideas into high-quality products. As a CDMO, our company is committed to optimizing every step of the manufacturing process to create high-quality diagnostic products for customers that reach the market and the people who need them safely and quickly. As an employer, we believe in fostering the unique talents of employees and recognizing hard work and teamwork to achieve the company’s mission.

“I love working at Launchworks because it’s a great balance of coming in to work while enjoying the culture around you to get that work done.” – Amanda, Quality Assurance Specialist

“I enjoy working for Launchworks because it is a dynamic and fast paced environment. At Launchworks I am continuously learning new technology and applications for the products we make. Above all, the culture at Launchworks truly allows you to grow into a position with the responsibilities you want out of it.” – Kait, Application Scientist & Principal Investigator

HOW YOU WILL CONTRIBUTE (Overall & Key Responsibilities):

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.
• 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
• Communicate effectively with vendors, clients, and internal stakeholders to reach project goals.
• Reviews QMS procedures for suitability and to identify opportunities for improvement.
• Interpretation and application of standards and regulations relevant to Quality Management System (QMS).
• 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).
• Lead the verification, validation and risk analysis process.
• Participation in audits.
• Backup 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)

WHY JOIN US:

At LaunchWorks, we strive to offer a comprehensive benefits package that helps you and your family maintain health and well-being -both physically and financially. Our comprehensive benefits package includes:

• Medical Insurance
• Dental Insurance
• Vision Insurance
• Health Savings Account (HSA)
• Flexible Spending Account (FSA)
• Voluntary Accident, Critical Illness, and Hospital Indemnity Insurance
• Basic Life and AD&D / Voluntary Life and AD&D
• Short-Term Disability
• Long-Term Disability
• Pet Insurance
• Commuter Transit Benefits
• 401(k) Retirement Plan w/Safe Harbor Employer Contribution
• Paid Holidays
• PTO 

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.