Quality Systems Specialist

About UFP MedTech: UFP Technologies is a designer and custom manufacturer of comprehensive solutions for medical devices, sterile packaging, and other highly engineered custom products. UFP is an important link in the medical device supply chain and a valued outsource partner to most of the top medical device manufacturers in the world. The Company\’s single-use and single-patient devices and components are used in a wide range of medical devices and packaging for minimally invasive surgery, infection prevention, wound care, wearables, orthopedic soft goods, and orthopedic implants. UFP Technologies, Inc. offers a competitive benefits package, including but not limited to: Medical, Dental, Vision, Life, Disability Insurance 401K with a matching contribution Paid time off, Paid holidays, Employee discounts and much more! Location: This position will be on-site full-time in Newburyport, MA. The position holder will need to be within commuting distance (within 45 min). Qualified applicants must be eligible to work in the United States to be considered for this opportunity. Employment based visa sponsorship (including H01B sponsorship) is not available for this position. Quality Systems Specialist Summary : The Quality Systems Specialist will provide quality systems support to Quality, Manufacturing, and R&D Engineers in QMS improvements, corrective and preventive actions, customer complaints, general project management and audits. This position will support process and planning decisions with knowledge of Quality System policies, practices, procedures, standards and regulations. Quality Systems Specialist Essential Duties and Responsibilities: Oversees the development and maintenance of quality systems programs, processes and procedures, ensuring compliance with policies and established regulatory standards. Participates in internal / external quality audits, prepares audit reports, initiates CAPAs or other activities as necessary. Provides expertise, guidance, and leads non-conformance and CAPA action plans to ensure key performance indicators are met. Accountable for customer complaints process to ensure complaints are addressed in an efficient and timely manner. Participates in continuous improvement initiatives within both the Quality Department and the Plant as a whole. Oversees and controls processes for handling non-conforming and returned products. Oversees rework is performed by following appropriate procedures and their documentation. Writes and updates procedures to support corrective actions. Collaborates cross-functionally to drive corrective actions to improve metrics. Reviews any outstanding CAPAs with management. Collaborates cross-functionally on complaint trend monitoring, evaluation, and investigation of signals and potential trends. Educates employees on Quality Management System Processes and compliance. Provides project management support. Participates in conducting both internal and vendor audits. Performs other similar duties as required by responsibility, necessity or as requested. Quality Systems Specialist Qualification Requirements : Bachelor\’s degree in Quality Assurance, Engineering, or Technology and 5 years of experience in a quality systems or manufacturing environment in regulated environment (medical device preferred) or equivalent combination of education and experience. Experience with 21 CFR Part 820 and ISO 13485. Project Management experience (preferred). Experience participating in external / internal audits. CAPA resolution expertise. Experienced at writing technical documents. Occasional travel may be required. To apply for this job please create a profile with us through our online application system. Click the \”Apply\” box in the upper right-hand corner to start the application process. Or, if you already have a social media account with LinkedIn, Google, or Facebook you can use your log in credentials to apply. For more information on UFP MedTech, visit www.ufpmedtech.com . UFP Technologies, Inc. is an Equal Opportunity/Affirmative Action employer Minorities/Women/Veterans/Disabled. #UFP #MEDTECH #NBPT #IND #J-18808-Ljbffr