Sr. Quality Control and Compliance Engineer

Job Description

Job Description

Senior Quality Control & Compliance Engineer

Location / Work Mode: On-site – Newbury, OH

Role Type: Full-time (Condensed Schedule: Mon–Thu 9 hrs, Fri 4 hrs)

Compensation: $85,000 – $100,000 per year + Performance-Based Bonus + 401(k) Match & Full Benefits

The Opportunity & Impact

A premier component manufacturer specializing in military communications and medical device technology is seeking a Senior Quality Control & Compliance Engineer to drive product excellence and regulatory integrity. Reporting directly to the Engineering Manager, you will serve across quality assurance and regulatory frameworks, taking ownership of customer complaints, audit readiness, and Quality Management System (QMS) performance.

Key Responsibilities

• Drive cross-functional root cause analysis and end-to-end resolution of customer complaints to eliminate repeat defects and elevate customer satisfaction.

• Maintain and execute QMS compliance protocols aligned with ISO 9001 and ISO 13485 standards across all engineering and manufacturing workflows.

• Support FDA regulatory requirements for medical device production by maintaining technical documentation, Device History Files (DHF), and audit-ready records.

• Lead multi-level audit initiatives , serving as a core representative for internal, third-party certification, customer, and FDA regulatory inspections.

• Provide expert technical guidance to quality inspectors on incoming raw materials, in-process testing, and final inspections for electronic assemblies and cable systems.

• Author, update, and govern essential quality documentation , including standardized inspection plans, standard operating procedures (SOPs), and quality records.

• Track, analyze, and report key quality performance metrics (such as scrap rates and defect trends) to steer continuous process improvements across operations.

Qualifications & Requirements

• Education & Field: Bachelor's degree in Engineering, Quality Assurance, Regulatory Affairs, or a related technical field (or equivalent hands-on industry experience).

• Industry Experience: Minimum 5 years of hands-on quality and compliance experience within electronics manufacturing, with strong preference for medical devices and cable assemblies.

• Standards Knowledge: Solid, practical working knowledge of ISO 9001 and ISO 13485 quality standards.

• Regulatory Familiarity: Practical understanding of FDA Quality System Regulations (QSR) and medical device compliance requirements.

• Core Skills: Proven track record in managing technical customer complaints, leading root-cause investigations, and establishing rigorous inspection plans.

• Auditing & Systems: Practical experience leading or supporting internal/external regulatory audits and managing robust QMS documentation.

• Technical Capabilities (Preferred): Familiarity with risk management principles (ISO 14971), process validation, statistical quality tools (SPC, Gage R&R), or ASQ/RAC certifications (CQE, CQA, RAC).

How to Apply

To apply for this opportunity, please submit your updated resume directly through our recruiting candidate portal or contact our talent specialist team to arrange a confidential introductory call.

#INDRBR