Manufacturing Quality Specialist

Job Title: Manufacturing Quality Specialist

Overview:

The Manufacturing Quality Specialist (MQS) is a full-time position. The MQS plays a key role in supporting day-to-day manufacturing operations by ensuring products are manufactured in accordance with approved specifications, procedures, and applicable regulatory requirements. This position provides quality oversight on the manufacturing floor through in-process inspections, manufacturing support, documentation development, production data analysis, and continuous improvement activities while ensuring compliance with Good Manufacturing Practices (GMPs). The Manufacturing Quality Specialist collaborates closely with Manufacturing, Engineering, and Quality to support the manufacture of implantable medical devices and their delivery systems within a fast-paced, growing organization.

Reports to: Director of Quality

Job Description :

The manufacturing quality specialist will:

·      Support manufacturing operations through routine floor presence and provide quality oversight during production activities.

·      Perform in-line and final inspections to verify product conformance to approved specifications, drawings, procedures, and acceptance criteria.

·      Review manufacturing documentation for completeness, accuracy, and compliance with Quality Management System requirements.

·      Develop, revise, and maintain manufacturing procedures, work instructions, travelers, and other production documentation.

·      Collaborate with Manufacturing and Engineering to improve manufacturing processes, documentation, and product quality.

·      Collect, analyze, and trend manufacturing and inspection data to identify opportunities for continuous process improvement.

·      Support investigations of nonconforming products and manufacturing issues by documenting findings and assisting with root cause analysis and corrective actions.

·      Ensure manufacturing activities are performed in accordance with GMPs, company procedures, and regulatory requirements.

·      Monitor production processes to ensure compliance with quality standards and identify opportunities to improve efficiency and reduce defects.

·      Participate in training production personnel on manufacturing procedures, quality requirements, and documentation practices.

·      Assist with internal audits, external inspections, and QMS activities as required.

·      Demonstrate flexibility and adaptability in a start-up environment, balancing multiple priorities while maintaining attention to detail.

·      Exhibit strong written and verbal communication skills.

Minimum Qualifications:

•        Associate's or Bachelor's degree in Engineering, Life Sciences, Manufacturing, Quality, or a related technical discipline, or equivalent combination of education and experience.

•        2–5 years of experience in Quality Control, Manufacturing Quality, or Quality Assurance within a regulated medical device environment.

•        Working knowledge of GMP, GDP, and quality system requirements within the medical device industry.

•        Experience performing inspections using inspection equipment and interpreting engineering drawings, specifications, and manufacturing documentation.

Abilities / Preferred Qualifications:

•        Experience supporting manufacturing in a regulated medical device environment.

•        Experience writing manufacturing procedures, work instructions, travelers, or controlled documentation.

•        Strong analytical and problem-solving skills with experience using production data to drive continuous improvement.

•        Familiarity with nonconformance management, CAPA, and root cause analysis methodologies.

•        Experience working within ISO 13485 and/or MDSAP Quality Management Systems.

•        Able to work independently while collaborating effectively across multiple departments.

•        High attention to detail.

•        Experience in a Cleanroom (any ISO Class).

•        Preferred proficiency with Microsoft Excel software.

•        Preferred familiarity with product line management (PLM) / quality management system (QMS) and material resource planning software.

Work Conditions:

•    This job requires frequent work in both office and manufacturing environments. Note that manufacturing location is in Bridgewater, MA.

•    This job may require prolonged periods of standing, walking, and performing detailed visual inspections.

•    This job may require lifting objects weighing up to 50 lbs.

•    This position requires adherence to cleanroom procedures and appropriate personal protective equipment (PPE) when working in controlled manufacturing areas.