Quality Assurance Supervisor

3 weeks ago

Philippines SomnoMed Philippines Full time

The role will report to Senior QA Manager at Central Production Facility (CPF).

As this hands-on position will oversee the practical and technical work necessary to ensure that the Central Production Facility (CPF) complies with all relevant and applicable medical device standards and regulations, strong leadership and team skills will be important in guiding and aligning the internal teams. The successful candidate must have an excellent understanding of the regulations that impact a medical device organization, strong manufacturing quality foundations, and a sufficient experience in supervising and managing quality operators and specialists.

Job responsibilities:

QA supervisor may handle any of the following sub-function roles: quality control, quality engineering, compliance, and quality events. Roles between several QA supervisors within the RAQA team may be rotated around these sub-functions depending on current employee capability and/or business needs.

GENERAL FUNCTIONS

- Drafts initial issuance or revisions to quality documentations, including but not limited to standard operating procedures, work instructions, records, test methods, quality control, change controls, deviations, corrective actions, validations, risk assessment and nonconformances investigations.

- Supervises and guides inspectors, technicians, and specialists to ensure processes are executed according to written procedures and quality metrics of different functions are met.

- Ensure availability of up-to-date administrative records (CV, job description, training log, etc) for quality operators, technicians, and specialists

- Manages staff training and ensures critical quality processes are done only by qualified and trained operators, technicians, and specialists.

- Proactively reports all detected areas of risk in their specific function areas and proposes mitigation plans.

- Communicate with in-house employees to build, enhance, and ensure quality awareness and regulatory compliance.

- Ensures the proper interface of the quality function to Product Development, Design Transfer, Manufacturing Operations, Supply Chain, and other identified areas as required.

- Maintains and enhances controls to constantly monitor and ensure the quality, regulatory compliance, and continual improvement in CPF operations.

QUALITY CONTROL FUNCTIONS

- Manages issues and provides tactical decisions within the operations of Incoming Quality Control, In-Process Quality Control, and Final Device Quality Control.

- Partners with operations teams to monitor products and processes to ensure conformance with specifications, standards, and regulations, and that quality issues are escalated on-time.

- Directs personnels involved in quality control and quality assurance processes to assure that standards and regulations are always met.

QUALITY ENGINEERING FUNCTIONS

- Manages issues and provides tactical decisions within the operations of Quality Engineering

- Assures the reliability and consistency of production by analyzing product and process data from manufacturing operations.

- Inputs any findings from analysis of data into design and process reviews for risk management and identification of improvement opportunities.

- Routinely reviews quality indicators and suggests for revisions and improvements as necessary.

- Supports validation activity in all operations at CPF operating within the QMS.

- Supports investigation activity of customer complaints and any other feedback from market and regulatory bodies.

COMPLIANCE FUNCTIONS

- Manages issues and provides tactical decisions within the operations of Compliance Functions (Documentation, Audits and Regulatory Inspections, Change Control, Risk Management, and Support to Different CPF functions).

- Monitors all internal processes to ensure that quality standards are implemented.

- Establish and ensure traceability systems are working properly.

- Actively participates in internal audits, external audits, and regulatory inspections, and ensures maintenance of all existing certifications.

- Partners with Supply Chain to ensure proper management of critical suppliers.

- Ensures proper control on changes within the CPF operations, including release by concession and deviations.

- Provides support to other functions within the CPF operations to ensure compliance with applicable standards and regulations.

QUALITY EVENTS FUNCTIONS

- Manages issues and provides tactical decisions within the operations of Quality Events Functions (Deviations and NC-CAPA Management for Non-Conforming Product Detected Before Delivery, for Non-Conforming Product Detected After Delivery, and for Non-Product Related Quality Events Like Audit and Regulatory Findings and Supplier NC's)

- Analyses internal and external feedback and conducts/arranges for initial investigations to confirm if feedback is a valid non-conformance and needs to be escalated to a formal NC process.

- Monitors execution and completion of Non-conformances and Corrective and Preventative Actions.

- Monitors execution and completion of Supplier Corrective Actions.

- Supervises post market surveillance activities, including collecting feedback information/data from hubs, analyzing data received, reporting adverse events, and related corrective/preventive actions.

- Escalates and manages quality events according to defined processes and standards.

OTHERS

- Performs other ad hoc assignments assigned by the superior or management to help support continual improvement and growth of the company.

Experience and Education:

- Bachelor's Degree in Life Sciences or Scientific Engineering is required.

- Preferably 3-5 years of collective experience in manufacturing quality control and assurance is required.

- Experience in leading and supervising quality control and quality assurance teams in manufacturing operations is required.

- Broad understanding of ISO 9001 is required. Understanding of ISO 13485 is desirable.

- Knowledge of US FDA 21 CFR 820 Quality Systems Regulation, EU Medical Device Regulation, and other regional quality regulations (e.g. Australian TGA) is preferred.

- Experience in executing process, computer systems, and test method validations is preferred.

- Excellent documentation and communication skills is required.

- Proficiency in Microsoft Office is required.

- Ability to deal with ambiguity.

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