Manufacturing Sr. Quality Engineer

PURPOSE

The Manufacturing Senior Quality Engineer establishes, implements, and maintains quality standards for products and manufacturing processes within a medical device contract manufacturing environment. This role identifies and mitigates quality risks throughout the product lifecycle, working closely with cross functional teams in engineering, production, supply chain, and product management. Responsibilities include driving process and supplier quality, conducting audits, leading root cause investigations, and ensuring compliance with ISO 13485 and FDA Quality Management System Regulation (QMSR).

DUTIES AND RESPONSIBILITIES:

Quality System & Compliance

• Assists management in implementing, maintaining, and improving a quality system compliant with ISO 13485 and FDA QMSR (21 CFR 820).
• Leads preparation for and participates in Customer, Notified Body, and FDA audits; provides SME support for manufacturing quality systems, validation, CAPA, and statistical control processes.
• Interprets and applies FDA and ISO requirements to supplier, manufacturing, and inspection processes.

Manufacturing & Supplier Quality

• Develops and maintains manufacturing control plans for internal and outsourced processes.
• Manages and oversees work performed by third party production suppliers/contractors to ensure conformance to procedures, specifications, and quality standards.
• Leads supplier and manufacturing process validation activities, including development or review of IQ/OQ/PQ protocols, statistical justification of sample sizes, and preparation or review of validation reports.
• Leads qualification of materials and components, including first article inspections, capability studies, Gage R&R, and SPC implementation.

Risk Management, Change Control & Design Transfer

• Evaluates design changes, material/component changes, and process changes for impact on MDF.
• Performs product and process risk assessments (hazard analysis, DFMEA, PFMEA).
• Leads activities to address gaps, including verification testing, documentation updates, and risk management revisions.

Statistical Analysis & Method Development

• Applies advanced statistical methods such as design of experiments (DOE), process capability, measurement system analysis (MSA), statistical process controls (SPC), and sampling plan design to evaluate and control supplier and internal manufacturing processes.
• Develops and validates inspection and test methods for design verification, in process inspection, and final acceptance activities.

Nonconformance & CAPA Leadership

• Leads complex root cause investigations using structured problem solving tools (5 Why, Fishbone, FTA, statistical data analysis).
• Ensures robust corrective and preventive actions are defined, verified for effectiveness, and implemented to prevent recurrence.
• Ensures timely processing of nonconformances and provides monthly metrics reporting.
• Collaborates with QA Technicians to develop incoming inspection procedures and inspection reports.

QUALIFICATIONS

• Bachelor of Science in Engineering, Technical, or related field (or equivalent experience). 
• Minimum 5 years of experience in Quality Engineering within a medical device Contract Manufacturing Organization (CMO) or regulated device environment. 
• Demonstrated experience leading process validation and statistical analysis in FDA-regulated manufacturing. 
• Strong expertise in the application of statistical tools (DOE, capability studies, MSA, automated test system validation, regression/modeling, sampling plans). 
• Demonstrates strong proficiency in GD&T and engineering drawings to guide design, process development, and inspection.
• Hands-on experience with Customer, Notified Body, and FDA audits. 
• Experience working in cleanroom manufacturing environments. 
• Experience with packaging for terminal sterilization (tray/lid, pouch) and sterile load release activities performed on behalf of customers. 
• Excellent verbal and written communication skills, including ability to train others. 
• Strong organizational, analytical, and problem-solving skills. 
• Proficiency in Microsoft Office Suite, Google Workspace, or similar tools. 
• Ability and willingness to inspect and/or review deliverables of others, up to your level of expertise, according to applicable defined Quality criteria

WORKING CONDITIONS

• Work performed in an office environment and on the manufacturing floor. 
• Prolonged periods of computer work. 
• Must be able to occasionally lift 15 pounds.