Our client has a Quality Tech role in the Lowell, MA area. The successful candidate will be responsible for ensuring our manufacturing site produces and distributes products which meet or exceed all established quality standards and will be responsible for ensuring our processes and procedures are compliant with corporate policies and federal law. The individual will be cross trained in all operations quality functions including executing incoming inspection on raw materials, performing in-process visual and measurement inspections from the cleanroom, and assessing the final product’s efficacy prior to market release. In addition to those activities, this position may also be required to support production operations, metrology, microbiology, or other manufacturing functions as business needs arise. This position requires a strong attention to detail, problem solving skills, and willingness to work in a fast-paced manufacturing environment.
• Inspect and record results of raw materials, work in progress, and finished goods at various stages of the production process to determine and maintain the quality and reliability of our product.
• Assess and complete inspection reports and records including the entry of data into various electronic systems. (For example – Excel, WinSPC, Electronic DHR systems, Oracle Agile, and others)
• Generate, review, and maintain quality records in support of the Quality System. (For example – device history records, non-conformance reports, corrective and preventative actions, internal audits, and training records)
• Review and track lot acceptance records and failure trends.
• Ensure the calibration status of all measuring and critical manufacturing equipment.
• Perform calibration of instrumentation and equipment which supports the manufacture and testing of product
• Assist the Quality Manager in notified body and regulatory authority audits and inspections.
• Works from specifications, work plans, procedures, and general instructions from either Quality Engineers or the Quality Manager.
• Perform internal audits as required.
• Required to perform laboratory activities within a cleanroom setting.
• Required to maintain and enforce cGMPs within the manufacturing operations.
• Safely follow standard operating procedures including but not limited to quality standards, material handling, and record keeping. Must follow all Good Manufacturing Practices (GMPs), Good Documentation Practices (GDPs), and Good Laboratory Practices (GLPs).
• Notifies Quality or Operations Leadership of any discrepancies to ensure quality standards and safety of operations are maintained at all times.
• Able to work in small groups and cross functional teams to troubleshoot issues, identify and implement collective corrective actions.
• Maintain a clean work environment suitable for medical device manufacturing and cleanroom production.
• Performs other duties as required
Education and Experience:
• High School diploma
• Minimum of 2 year in a Quality related function working within a regulated environment.
Preferred Skills and Competencies:
• Excels at generating and maintaining organized and accurate records.
• Basic computer skills are required. Proficient use of MS Office products (Excel, Word at a minimum) is a plus.
• Self-starter capable of dealing with a variety of tasks in a fast paced, multi-tasking environment.
• Must be proficient in English language to be able to read documentation, communicate, and write.
• Ideal candidate will have keen eye for quality, is dependable, and will work collaboratively within a team, and possess a positive attitude. The candidate will have an uncompromising adherence to quality standards.
• Experience in 21 CFR part 820 and 11, and ISO 13485 regulations.
• Familiarity with measurement instrumentations such as micrometers, calipers, tensile testers, video microscopes, and optical gauging products.
• Ability to read and understand engineering drawings for machined parts.
• Experience with discreet assembly.
• Experience working in a clean room environment in the medical device industry.
• Experience in a start-up production environment.
• Core Competencies:
• Production & Processing – Knowledge of raw materials, measurement instruments, production processes, quality control, and other techniques for the manufacture and distribution of goods.
• Mathematics – Basic mathematics skills (adding, subtracting, multiplying, dividing)
• Problem Solving – Recognizes problems and understands root cause analysis techniques/concepts.
• Detail Oriented – Excellent attention to detail and good organization
• Autonomy - Capable of working independently with minimal instruction from their supervisor.
Physical Requirements (if applicable):
• Required to stand for at least 75% of working time per shift, with walking at least 50% of working time per shift.
• Required to reach above shoulder frequently and below waist occasionally.
• Required to push and pull.
• Ability to lift up to 20lbs occasionally, 5-20lbs frequently.
Connexion Systems & Engineering, Inc.
Why Work Here?Connexion is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.
Extremely innovative and fast growing firm with an excellent industry reputation combined with a ton of room for growth!