Description: This is a NonExempt position Summary Perform a wide variety of activities to support the Quality Management System. Essential Duties and Responsibilities - Conduct product testing including testing to support complaint investigations and stability verification - Generate product testing results reports - Review production batch records DHR's for accuracy and completeness in order to approve intermediate products for use in production. Review finished goods batch records. Report all deviations in these records and assures these have been addressed and resolved prior to issuing approval. - Conduct spot-check inspections/audits of production operations - Participate in the internal audit program - Write review and approve Standard Operating Procedures SOPs as necessary - May assist in supporting the Document Control program record retention areas and sample retention areas - May support returned instrument processing o Log returned instruments from the field. o Decontaminate returned instruments in a Biohazard level II environment following standard operating procedure and documenting decontamination as required. o Inspect returned instruments for damage and performing basic investigation and documenting results prior to second level processing. o As necessary process instrument documentation for return to repair facility and pack instruments as required. Other duties as assigned by supervisor Supervisory Responsibilities This job has no supervisory responsibilities. Qualifications To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Ability to follow Good Manufacturing/Laboratory Practices GMP and GLP Education and/or Experience Bachelor's degree in a scientific or technical area or equivalent combination of experience and education. At least one year in quality assurance role in medical device industry is preferred. Language Skills Ability to read and interpret documents such as safety rules operating and maintenance instructions and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before small groups of customers or employees of organization. Mathematical Skills Ability to apply concepts such as fractions percentages ratios and proportions to practical situations. Computer Skills To perform this job successfully an individual should have knowledge of Database software Internet software Inventory software Spreadsheet software and Word Processing software. Certificates Licenses Registrations - None Other Skills and Abilities Ability to follow procedures and accurately document results Understanding the manufacturing processes of Company products and ability to recognize deviations from approved documented procedures Attention to detail. Ability to use bleach for cleaning purposes is required. Other Qualifications - None Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job the employee is regularly required to sit and stand. The employee is occasionally required to walk. Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Additional Skills & Qualifications: BA/BS degree in chemistry or biology preferred but not required if candidate has equivalent experience Preferred experiential background : 0-2 years’ experience with FDA Class I/II device or other regulated industry preferred. Proficient in spoken and written English Excellent interpersonal skills About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.