Quality Control

**Primary Job Responsibilities**:

- Sustain an active Quality Management System, such as Management Review, Internal Audit, CAPAs, NCRs, Document Control, Change Control, Risk Management and Training.
- Establishes, reviews, maintains and improves quality documents (e.g., SOPs, specifications, methods, records, etc.) to ensure compliance with ISO 13485, MDR 2017/745, and 21 CFR part 820 requirements.
- Ensure the documentation system complies with regulatory and ISO requirements as a Document controller. Coordinate to update the Master list for all documentation such as calibration program, service report, sterilization validation plan and Product/Material code. To maintain QMS, DHF, DMR, DHR and Technical Files.
- Establishes and/or reviews quality instructions, sampling plans, inspection plans, quality control documentation, and records to which the quality technicians must conform.
- Coordinate and supervise the inspection of raw materials, components, sub-assemblies, and finished goods. Coordinate with vendors to resolve incoming/finished goods/customer quality issues. Release product from quarantine into finished goods by reviewing product packaging, labelling and sterilization data sheets.
- Ensure that quality instruments and equipment are well maintained and calibrated on a regular basis.
- Work closely with cross-functional teams (Operations, Procurement, R&D, Engineering, Regulatory).
- Promote audit readiness, prepare Merlin’s team for audits by external bodies, including NB, FDA, and facilitate audits as needed. Interface with inspectors and NB auditors during inspections and provide post-inspection follow-up information as requested.
- Manage day-to-day execution of the quality control, and quality assurance activities facilitate and implement improvements to the quality system while maintaining compliance with applicable Quality System Regulations and ISO standards.

**Secondary Job Responsibilities**:

- Conduct regular reviews, reports, and presentations of product quality metrics. Analyze quality data monthly using statistical data analysis methods.
- Ensure that quality objectives are met, develop quality plans and activities to comply with quality policies, and identify opportunities for efficiency improvement.
- Serves as a quality team member on new product development projects and for Quality Control activities of existing products.
- Participate and assist in regulatory submitting and reporting compliance with the requirements and relevant standards or guidance.
- Any other tasks or projects assigned by the immediate supervisor, as and when required.

**Minimum Education Required**:
Bachelor’s degree in life sciences, engineering, or equivalent (Diploma in life sciences, engineering, or equivalent with 2 years of experience)

Prefer CEQ/ISO Certification

**Additional Qualifications Required**:
Knowledgeable with the Quality Management System and ISO 13485, US FDA 21 CFR part 820

Knowledge of MDR 2017/745 Medical Device requirement
- Familiarity with Quality Assurance techniques
- Proficient in Microsoft Office (Word, PowerPoint, Excel, etc.)

Excellent problem-solving skills with demonstrated experience leading terms to resolve complex and multi-disciplinary issues.

Excellent communication skills (ability to read, understand and explain GMP Process procedure and other necessary documentation)

Able to communicate, both verbal and written, effectively and clearly

Able to work independently with mínimal supervision.

Able to support product development, manufacturing, and release.

Ability to perform other activities in support administration, product development, manufacturing and release as directed by Senior Management

**Minimum Experience**:
Minimum 2 years of related experience in the medical device or related industry.

**Supervisory Responsibilities**:Quality inspectors
- **Working Conditions**:Office environment &Controlled production area (Cleanroom)

An applicant should not have any medical conditions preventing access to the controlled production areas.