Job Title: Consumables Assembler Job Description: The Consumables Assembler position requires a skilled candidate responsible for conducting consumables manufacturing activities including assembly, packaging and kitting of cartridges, controls and other consumables in support of product development and commercial sales. This includes all manufacturing assembly related functions such as parts inspection and reprocessing as necessary, inventory monitoring and organization, Inventory transacting and Identifying assembly process improvements opportunities. Key Responsibilities and Required Skills:
- Inspection and reprocessing of incoming parts to ensure they meet desired standard before considering as viable inventory items to be used in daily manufacturing activities.
- Manufacturing of Sub-assemblies/ Intermediates and Finished Goods consumables in compliance with 21 CFR part 820 and ISO 13485 quality systems.
- Population of moisture-sensitive and delicate Lyophilized Beaded Reagents into Fluid cards with extreme accuracy consistently over specific segments of time. This task requires the ability to focus and work with precision in a dynamic workplace environment.
- Adhering to quality records with great attention to detail to ensure performing manufacturing assembly activities as optimally designed for intended use.
- Conducting consumables manufacturing activities within set timelines.
- Collaborating with team members within manufacturing as well as other groups to understand manufacturing requirements clearly and thoroughly for standard and custom builds.
- Responsible for dual control Inspection activities as described in manufacturing processes to ensure layering multiple check points throughout the manufacturing workflow.
- Ability to operate automated or semi-automated equipment to help increase manufacturing throughout as deemed necessary for scaling up.
- Reporting any issues to supervisor and department manager to limit potential assay failures that could be the result of faulty parts or sub-optimal processes.
Required Education/Experience/Characteristics:
- High School Diploma with relevant work experience in Biotech manufacturing or similar industry preferred. Associate degree in Engineering or related technical discipline desired.
- Minimum of 1-2 years of medical device manufacturing experience or related industry required.
- Ability to communicate manufacturing issues clearly verbally and in writing as necessary.
- Ability to problem solve/ troubleshoot manufacturing related issues to help with continuous improvements in a dynamic star-up environment.
- Ability to handle the pressuring demands of a fast-paced environment where priorities shift regularly.
- Strong interpersonal and communication skills and willingness to collaborate with colleagues on daily basis in culturally diverse environment.
EEO EmployerApex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-###-#### .Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.