Quality Controller - Quality Assurance

About the role

Provide quality assurance services to ensure the integrity of products received and shipped out, services provided to clients, and compliance with government regulations, industry, and OpCo standards. Responsibilities may include supplier selection and auditing, material qualification, inspection and testing, performance monitoring, supplier development, and managing process and product non-conformances. The role supports quality assurance activities across the product lifecycle, including inspection of incoming materials, in-process products, and finished devices, as well as complaint investigations, nonconforming material management, validation activities, and continuous improvement initiatives.

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.
• 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.

Requirements

• 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 in English.

Preferred Skills

• One to three years’ related experience and/or training, preferably in the Medical Device or Pharmaceutical industry or technical field.
• 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).
• Support Oracle product configuration and BOM maintenance activities is desired.
• 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.
• 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.
• Detail orientation, precise work, excellent verbal and written communication skills, ability to collaborate effectively across multifunctional teams.

Pay

$23.10 - $26.00 per hour

Benefits

• Annual performance bonus
• Medical, dental, and vision benefits
• 401K match
• Other applicable compensation plans