Job Description:

Position Overview:As a Quality Assurance Engineer-Validation Specialist, you will be a major part of the QA Department and will serve as the go-to for day-to-day operationsinvestigations 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 software 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 andor 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 qualificationKey ResponsibilitiesEquipment & software 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 processesequipment 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 terpretation 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 andor 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.Minimum QualificationsBachelors 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 environmentAt least 1-2 years' experience working in a regulated industryMicrosoft Office, ERP, QMSRequired CompetenciesStrong 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 skillsAbility 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 companyProven ability to thrive in a change-oriented environmentConfident working in quality assurance, quality control and Quality Management Systems (ISO 9001 or ISO 13485)Why Join Us:Our comprehensive benefits package includes:Medical, Dental, and Vision InsuranceHealth Savings AccountFlexible Spending AccountVoluntary Accident, Hospital Indemnity, and Critical Illness InsuranceBasic & Voluntary Life and AD&D InsuranceShort-Term & Long-Term DisabilityPet InsuranceCommuter Transit Benefits401(k) Retirement PlanPaid Time OffPaid HolidaysIt is our 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.