Executive - Quality Assurance & Quality Control

Position:

Position Reports to:

Downline Reporting:

Department:

Location:

Job Responsibilities:

• Maintain Safe & Healthy work environment by following standards and procedures and complying with organization policies.
• Focus on Company Vision, Mission & share its values. Exhibit commitment to business ethics & demonstrate high level of personal integrity.
• Ensure the 5S and GMP practices in the department and maintenance of laboratory equipment and premises. Involve and co-operate in the implementation of best practices initiatives.
• Understand the Quality Management Systems requirements and aware of MDSAP, ISO 13485, 21 CFR part 820 and other applicable requirements.
• Ensure the awareness of the Quality Policy, Quality Objectives & EHS Policies in the department and Implement the applicable procedures for in-process and final release activities.
• Approve and release in-process production by confirming required specifications and Return products for re-work if needed and confirm the re-worked products confirms to required specification.
• Ensure the Control of Documents, Records and its distribution. Document and update inspection and testing results by completing reports and logs.
• Approve finished products by confirming specifications and reviewing the tests results.
• Coordinate and Communicating with other departments such as Dipping, ET, Foiling & Packing for scheduling testing and Product release and assess product/ process issues and corrective actions.
• Plan and allocate the Manpower for In-process checks and final release inspection & sampling based on the production plan and ensure the activities are carried out as per the established procedures.
• Review the process and process records and Conduct Process audit of manufacturing process and report to Manager QA/ Manager In-process.
• Ensure the line clearance process in all the stages of process and review the testing results at each stage and approve the product to next stage.
• Control of non-conformance products during in process releases and final release and ensure the disposition of non-conforming products as per the procedures and related documentations.
• Review and analyse the training needs and Train the subordinates related to Testing methods, Device Defective analysis, Results review and reporting etc.
• Involve the Process Validation and Stability activities and update the prepare the report.
• Coordinate with the logistics team in getting the Production plan and verify and ensure the latest brand specifications are available at relevant stages.
• Review the DHR of the goods being released and ensure that the process was done in accordance with the specifications & Procedures. Review the test results, Compile & prepare the certificate of analysis for all batches on completion of final release testing.
• Analyze the defects observed in In-process and Final release inspection & testing and report the findings to respective department and Manager QA/Manger Technical for the further action.
• Initiate MRB/CAR for the non-conformance/non-conformity identified in the process / product and follow-up with the respective personnel for the correction/corrective action and monitor the effectiveness.
• Ability to achieve respective Quality KPIs and Department KPIs as per the targets.
• Approval of WIP Production in ERP system. Involve Internal Audits and ensure that the completion of the actions as per the schedule.
• Maintain the department documents and updation of reports as per the requirements.

Calibration & Equipment Maintenance

• Ensure testing equipment is calibrated and functioning properly.
• Maintain records of calibration and maintenance schedules.

Documentation & Record-Keeping

• Maintain detailed records of test results, inspections, and deviations.
• Prepare reports on quality trends, failures, and corrective actions.

Defect Identification & Root Cause Analysis

• Identify product defects and deviations from specifications, work with production teams to resolve quality issues.
• Implement corrective actions to prevent recurring defects.
• Follow-up for the effective implementation of all Corrective actions taken from complaints, non-conforming products and reporting to MR.
• Ensure Zero injuries at workplace and Reporting of EHS activities / concerns / incidents / near miss and accidents.
• To ensure that the laboratory activities are carried out by impartially & the personnel of the laboratory, either internal or external, that could influence the laboratory activities shall act impartially & be competent.
• Responsible to maintain Confidentiality of all information obtained or created during the performance of laboratory activities.
• Responsible to monitor and record environmental conditions of laboratory in accordance with relevant specifications methods or procedures and report any abnormalities.

About the Company

LifeStyles has a history dating back to 1905

Today LifeStyles is a Global leader in the sexual wellness sector, comprising a broad range of condoms, personal lubricants, and other related products and other products in over 60 countries.

Owning a large portfolio of trademarks, LifeStyles manufactures and commercialises its products either under leading global non-latex condom brands SKYN® under its local heroes such as LifeStyles®, Manix®, Unimil®, and Blowtex® and Control®.

Outside of branded products, the Company also supports universities, NGOs, and other organizations as part of a broader effort to promote sexual health and prevent the spread of STDs and STIs. LifeStyles owns and operates manufacturing facilities in Thailand, India and Spain, and it employs over 1,600 teammates globally.

LifeStyles Healthcare was created on September 1, 2017

As of December 1, 2022, Lifestyles is owned by Linden Capital Partners

This is an exciting time to join us. We combine century-long history with the opportunity of a new beginning as a stand-alone company - this means a new way of thinking, the opportunity to explore new horizons and the chance to make a mark in an exciting, fresh business.

LifeStyles Healthcare is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

“best of the best.”

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Discover more about us at: https://www.linkedin.com/company/lifestyles-healthcare/.

Curious to know what does every day look like at LifeStyles?

Find out by looking at employee testimonials: https://lifestylesglobal.com/careers

Due to the high number of applications, we would like to inform you that only selected candidates will be contacted.