Job responsibilities:

QA Specialist/Analyst I handles activities under at least 1 sub-function of QA-RA department. Tasks between several QA Specialists within the QA-RA team may be rotated depending on current employee capabilities and/or business needs.

GENERAL FUNCTIONS

- May assist in drafting 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.

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

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

- Assists in ensuring 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 of products and processes at SPI.

- Acts as quality partners to all the functions within SPI operations and provides needed support to ensure these functions are operating in compliance with internal policies and procedures and applicable standards and regulations. These may include, but not limited to, procedure reviews, creation of QMScompliant record templates, providing advises on how to ensure compliance to applicable management standards and country-specific regulations, etc.

QUALITY SYSTEM FUNCTIONS

- Manages controlled documents and maintains records. Responsible in upkeep of documents and records masterlist, including those of external origin.

- Maintains site master file

- Prepares and conducts quality-related trainings to all SPI employees.

- Supports the lead and coordinator during certification audits, regulatory inspections, and other external audits.

- Participates in internal audits and quality walkthroughs. May help prepare audit plans, audit program, audit checklists, organizes necessary meetings, and raise related NCs. - Manages and ensures enough controls on changes relating to document, product, and processes are available at SPI

- Monitors all internal processes to ensure that quality standards are implemented. - Establish and ensure traceability systems are working properly.

- Partners with Supply Chain to ensure proper management of critical suppliers and performs activities to ensure enough controls are available. This may include, but not limited to, maintenance of supplier master lists, initiating and maintenance of supplier evaluations, conducting supplier audits, developing quality agreements, etc.

- Monitors updates to applicable standards, regulations, and legislations and works together with the team to identify gaps and recommends actions to close these gaps.

QUALITY EVENTS FUNCTIONS

- Performs and manages activities related to quality events (deviation, concession releases, nonconformance reports and corrective/preventive actions) for non-conforming products detected before delivery, non-conforming products detected after delivery, and other non-product quality events (audit findings, regulatory inspection deficiencies, supplier NCs, etc).

- Monitors non-conformance reports and planned corrective and preventive actions and coordinates with the different SPI functions on on-time closure and monitoring of CAPA effectivities.

- Monitors execution and completion of Supplier Corrective Actions for SomnoMed hubs. - Attends regional quality meetings and prepares necessary information needed and/or inputs information from these meeting to SPI’s feedback system.

- Manages feedback from internal and external sources, initiates necessary investigations and discussions, provide responses to feedback sources

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

- Maintains related registers to ensure tracking of activities are efficient and accurate. - 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.

- 3-5 years of collective experience in manufacturing quality control and assurance is required, preferably in medical device or pharmaceutical industry.

- 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 document control, trainings, and supplier quality management may be required, depending on what sub-function the employee will be assigned to.

- Experience in executing process, computer systems, and test method validations may be required, depending on what sub-function the employee will be assigned to.

- Excellent documentation and communication skills is required.

- Proficiency in Microsoft Office is required.

- Ability to deal with ambiguity.

Job summary QA Specialist I handles activities under at least 1 sub-function of QA-RA department.

Please refer to job description.