Production Quality Manager

TN United Kingdom; Oxford; On-site; GBP 40,000 - 70,000; Full time

Job summary

An established industry player is seeking a Quality Control Manager to lead quality assurance efforts in the Medical Devices or Electronics Manufacturing sector. This pivotal role involves overseeing quality control processes to ensure compliance with regulatory standards and continuous improvement initiatives. The ideal candidate will possess a strong background in quality control methodologies and regulatory requirements, driving product excellence and customer satisfaction. Join a dynamic team where your expertise will significantly impact product quality and operational success.

Qualifications

• Experience with quality control tools and methodologies.
• Familiarity with regulatory requirements in the medical device industry.

Responsibilities

• Oversee and manage quality control within the organization.
• Ensure products meet quality standards and regulatory requirements.

Skills

Statistical Process Control (SPC)

Failure Mode and Effects Analysis (FMEA)

Root Cause Analysis (RCA)

ISO 13485

FDA Regulations

Non-Conformances and CAPAs

Validation and Verification Documentation

Internal and External Supplier Audits

Internal Auditor Training

Job description

The Quality Control Manager in the field of Medical Devices or Electronics Manufacturing is responsible for overseeing and managing all aspects of quality control within the organization. This role involves ensuring that products meet established quality standards and regulatory requirements, identifying and addressing any quality issues, and implementing continuous improvement initiatives to enhance overall product quality and customer satisfaction.

Key skills:

1. Experience with quality control tools and methodologies, such as statistical process control (SPC), failure mode and effects analysis (FMEA), and root cause analysis (RCA) – BS EN ISO 14971:2021.
2. Familiarity with regulatory requirements and quality standards in the medical device industry, such as ISO 13485 and FDA regulations.
3. Issuance of exception documents, such as Non-Conformances and CAPAs.
4. Generation of Validation and Verification documentation and testing reports.
5. Experience in performing Internal and External Supplier Audits.
6. Internal Auditor Trained.