Quality Controller - Quality Assurance

About this role

Job Description: Provide quality assurance services to ensure the integrity of products received and shipped out, services provided to clients, support business and customer needs, and comply with government regulations, industry and OpCo standards. May be responsible for supplier selection & auditing, material qualification, material inspection and test, performance monitoring and supplier development. May manage process and product non-conformances in line with company procedures. May conduct quality assurance tests to ensure product specifications are met. May review, investigate, resolve and report on quality discrepancies. May develop, maintain, monitor, and audit quality management system and protocols including systems automation, processes, and procedures that ensure compliance with regulations and standards. May monitor, investigate, and report on customer complaints. May obtain the necessary quality system certifications and licenses (e.g. ISO, CE) to support market release of new product development. May lead audit and inspection preparation, resolution of audit and inspection findings. May have frequent interaction with other functional areas and operating entities.

The Quality Controller is responsible for supporting quality assurance activities across the product lifecycle to ensure compliance with applicable regulatory, quality system, and product requirements. This role performs inspection activities for incoming materials, in-process products, and finished devices while also supporting complaint investigations, nonconforming material management, validation activities, continuous improvement initiatives, and cross-functional quality projects. The Quality Controller works closely with Manufacturing, Engineering, Operations, and R&D to promote product quality, compliance, and process effectiveness.

Essential Duties and Responsibilities: • Perform inspection and testing activities for incoming materials, in-process products, and finished devices to ensure compliance with established specifications and acceptance criteria.  • Document inspection and testing results in accordance with Good Documentation Practices (GDP).  • Identify, document, and assist with investigation of nonconforming materials, products, and processes.  • Support Material Review Board (MRB) activities including product evaluation and disposition activities.  • Participate in complaint handling activities including complaint evaluation, investigation support, MDR assessments, and closure activities.  • Support validation and verification activities including protocol execution, data collection, test documentation, and report generation.  • Collaborate with Manufacturing, Engineering, Supply Chain, and R&D to evaluate process changes, product improvements, and quality concerns.  • Assist with implementation of quality improvements and continuous improvement initiatives.  • Support internal and external audits, inspections, and quality system activities as needed.  • Participate in development, review, and maintenance of procedures, work instructions, forms, and quality records.  • Analyze quality data and communicate trends, observations, and potential risks.  • Serve as a flexible quality resource supporting multiple Quality Assurance functions based on business needs.  • Perform other duties as assigned. 

Incidental Duties: The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

Job Requirements: Job Requirements Education and Proficiency: • High School diploma or equivalent. • 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 communicate effectively with groups of employees within the organization. • Ability to perform these functions in English.

Preferred Skills: • Experience:  One to three years’ related experience and/or training, preferably in the Medical Device or Pharmaceutical industry or technical field. • Computer Skills : Experience working with electronic business systems (e.g., Word, Excel, Oracle, SAP). Familiarity with product data management, Bills of Material (BOMs), item master records, and Engineering Change Orders (ECOs) are preferred. Support Oracle product configuration and support BOM maintenance activities is desired. • Math Ability: Ability to add, subtract, multiply and divide in all units of measure, using whole numbers and decimals.  • Technical Skills : Experience with basic inspection techniques and tools (use of micrometers, calipers, lensometers, etc.). Able to understand product applications, specifications, functionality, structure, assembly and test methods/processes. • Reasoning Ability : Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions.  Ability to deal with problems involving multiple variables in standardized situations. • Abilities : Detail orientation, precise work, excellent verbal and written communication skills, ability to collaborate effectively across multifunctional teams.

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 .

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. • Employee is required to sit at a desk for long periods of time • Frequently uses hands and fingers, occasionally reaches up/do

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