Quality Assurance - Engineer

Job Description

Position: Quality Assurance Engineer

Position Reports to: Quality Manager EMO & Supplier Management

Department: Quality

Location: Surat Thani, Thailand

General Summary of the Position

This role of QA Engineer is to act as single point contact within Lifestyles business for all critical raw materials suppliers and critical external manufacturing organizations.

The role will report into Quality Manager, EMO and Supplier Management and will support him/her in daily operational activities for all reactive and proactive quality issues and tracking/monitoring supplier performance.

The role will be based at Bangkok or Surat Thani but will be responsible for all manufacturing sites and all external sourcing partners which requires the selected candidate to have high abilities in English language communications and cross-cultural remote working background. The roles require close working with manufacturing, QC and procurement etc.

Responsibilities & Specific Accountabilities

Main responsibility is as following.

Control & Monitoring of Supplier Quality Performance

• Product & Service Evaluation
• Quality System Audit
• Complaint System
• Change Control Process

Creation and control of specifications for externally manufactured products e.g. condom, lubricant and sex toys.

Responsible to ensure that the controlling of the Quality System for outsourced supplier is adequate documented, maintained, effective and complied to, to meet the requirements of relevant Quality System standards, including:

• Product and Service Evaluation
• Quality system audit for supplier
• Responsible for initiating Product specification/Modification of Product Specifications
• Products Master List Maintenance

Maintaining of existing supplier database

• Supplier Performance Evaluation
• Monitoring the supplier quality performance

Change Control Process Change Process

• Flow Request
• Change Process Activity Follow-up
• Approval of the Changes Activity

Complaint System: Manage all the customer complaints from complaint database and analysing report for monthly review

• Compliant Entry/Feedback
• Compliant Closure
• Complaint Trend Monitoring

After Market Surveillance Report Preparation

• Review requirements and specifications to enhance and improve the current process/procedure, to prevent recurring defects
• Identify, document and track defects during production for improvement and preventive action. Participate in risk assessment and root cause analysis Reporting/identified quality issues to senior QA staff, including detailed descriptions of problems and potential corrective action
• Reviewing supplier documentation and quality certificates to ensure compliance with company standards
• Prepares reports, analyses data and assists management implement action plans to achieve the goal/target
• Support for collection and compilation of technical files for products with CE Requirements
• Responsible for supporting the quality assurance process to ensure our products meet the highest standards, to identify and resolve quality issues in the plants, perform tests and contribute to continuous improvement projects etc.

Key Position Requirements

Education

• Preferable a bachelor's degree holder in Science or Engineering (Industrial Engineering, Mechanical Engineering)
• Hands on experience with relevant Quality System standards documentation and execution

Job Experience

• Trained and certified with ISO standards such as ISO 9001, ISO 13485 etc.
• Minimum 3 years in the quality control or assurance and testing lab management field.
• Working experience that related e.g. ISO ISO9001, ISO13485, ISO/IEC17025, ISO 14971, MDD93/42/EEC, CE mark, QSR, ASTM, WHO standard etc.
• Prior experience in medical device, pharma/healthcare quality would be advantage

Knowledge and Skills

• Professional English Communication skill
• Supplier Management Control Process
• ISO 9001, ISO13485, 21 CFR S820 Quality System Regulations Knowledge
• Familiarity with concepts like quality standards, compliance, and root cause analysis
• Proficiency in relevant software applications for data recording and analysis
• Ability to work effectively within a team to achieve quality objectives
• Versatility, flexibility, and a willingness to work enthusiastically within a constantly changing environment

Desirable Job Competencies

• Customer Focus
• Personnel Learning (Self Development)
• Perseverance
• Ethics and Values

Additional Requirements (travel, etc.)

• Able to travel domestic/overseas
• Computer skills (Microsoft Word/Excel/PowerPoint/e-mail)
• Comply with and monitor work practices according to LifeStyles's Ethical Business Conduct Policy
• Monitor and comply to local, regional and as per LifeStyles policy manifested Human Rights principles.
• Maintain proper crisis management and response plans for proper and timely crisis responses.

About the Company

LifeStyles has a history dating back to 1905 when Eric Ansell first started making condoms in Richmond Australia.

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.

The LifeStyles family of brands includes the #1 global non-latex condom brand, SKYN, Owning a large portfolio of trademarks, LifeStyles manufactures and commercialises its products, under its local heroes such as Mates, LifeStyles, Manix, Unimil, and Blowtex and Control. The brands values are centered around sex positivity, pleasure, confidence and inclusivity.

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, when the consortium of Humanwell Healthcare & CITIC Capital private equity purchased the Sexual Wellness division from Ansell.

As of December 1, 2022, Lifestyles is owned by Linden Capital Partners, a Chicago-based private equity firm focused on the healthcare industry.

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.

We are empowered professionals, and we are committed to creating a team of the world's best of the best. Our business foundation is strong, among our values are Integrity and Respect, our people are highly engaged. We have a focus on safety and teamwork - and we want you to join us! If you're looking for a daring opportunity to build brands in this booming & thrilling category, then let's talk.

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.