Senior Manager - Quality

Job Description

Position Title: Senior Manager – Quality

Position Reports to : Director of Quality

Department: Quality Assurance

Location: Surat Thani

Position Overview

The Senior Manager – Quality is responsible for providing strategic leadership and oversight of the Quality Management System (QMS) for medical device manufacturing operations, specifically condom production.

The role ensures full compliance with applicable international standards, regulatory requirements, and company quality policies while maintaining the highest standards of product safety, quality, and reliability.

This position leads QMS, quality assurance, quality control, laboratory operations, supplier quality, and regulatory compliance activities.

The Senior Manager – Quality partners with cross-functional teams to strengthen quality culture, drive continuous improvement initiatives, and ensure consistent delivery of compliant and high-quality products to global markets.

Key Responsibilities

Quality Management System Leadership

• Lead the development, implementation, and continuous improvement of the Quality Management System in compliance with international standards including ISO 13485, ISO 17025, MDR, MDSAP, ISO 14971, and other applicable regulatory requirements.
• Establish and maintain quality policies, procedures, SOPs, and operational standards aligned with global medical device regulatory frameworks.
• Ensure effective management of document control, change control, deviation handling, and quality records within the QMS.
• Promote company-wide adherence to quality standards and regulatory expectations.

Product Quality and Compliance

• Ensure that all manufactured products meet applicable international standards, regulatory requirements, and customer specifications.
• Oversee product quality performance across manufacturing processes and finished product release.
• Drive product quality improvements through data analysis and process optimization.

Quality Control and Laboratory Operations

• Provide leadership for QC and QA functions including incoming inspection, in-process monitoring, and final product release testing.
• Ensure laboratory operations comply with validated methods, ISO 17025 requirements, and internal quality standards.
• Oversee calibration, validation, and maintenance of testing equipment and laboratory instruments.

CAPA and Risk Management

• Lead the organization's Corrective and Preventive Action (CAPA) program to address non-conformities, product issues, and process deviations.
• Facilitate root cause investigations and ensure timely implementation of effective corrective actions.
• Implement and maintain risk management processes aligned with ISO 14971 and integrate risk-based decision-making into quality systems.

Customer Complaint and Post-Market Surveillance

• Manage customer complaints, field feedback, and post-market quality monitoring processes.
• Conduct product investigations and coordinate cross-functional responses to quality concerns.
• Ensure timely communication and reporting to regulatory authorities and customers where required.

Supplier Quality Management

• Establish and maintain supplier qualification, approval, and monitoring programs.
• Conduct supplier audits and implement supplier performance management processes.
• Ensure quality compliance of raw materials including latex, chemicals, and packaging components.

Regulatory Compliance and Audit Management

• Lead preparation and management of internal and external audits including certification bodies and regulatory inspections.
• Serve as the primary liaison with regulatory authorities, notified bodies, and external auditors.
• Ensure ongoing compliance with global medical device regulatory frameworks and certification requirements.
• Develop and execute the internal audit program to maintain audit readiness.

Continuous Improvement and Quality Excellence

• Drive continuous improvement initiatives across manufacturing and quality processes.
• Apply structured methodologies such as Six Sigma, Lean Manufacturing, and Statistical Process Control (SPC).
• Monitor, analyze, and report key quality performance indicators including defect rates, non-conformance trends, and audit outcomes.

Leadership and Talent Development

• Lead, mentor, and develop quality assurance, quality control, and laboratory teams.
• Strengthen organizational quality capability through structured training and competency development.
• Foster a culture of quality, accountability, and continuous improvement throughout the organization.

Qualifications

Education

Bachelor's or Master's degree in one of the following disciplines:

• Chemical Engineering
• Polymer Engineering
• Biotechnology
• Pharmaceutical Sciences
• Quality Management or a related technical field

Professional Experience

• 10–15 years of progressive experience in quality management within medical device, rubber/latex, or pharmaceutical manufacturing environments.
• Minimum of 5 years in a leadership or managerial capacity overseeing quality systems and teams.
• Demonstrated experience managing regulatory audits and implementing global quality standards.

Technical Competencies

• Strong knowledge of medical device quality standards and regulations, including ISO 13485, ISO 4074, ISO 14971, MDR, and MDSAP.
• Experience with laboratory quality systems aligned with ISO 17025.
• Expertise in quality tools and methodologies including:
• Root Cause Analysis
• Statistical Process Control (SPC)
• Failure Mode and Effects Analysis (FMEA)
• Corrective and Preventive Action (CAPA)

Leadership Competencies

• Strong strategic leadership and decision-making capabilities.
• Excellent communication and stakeholder management skills.
• Ability to influence cross-functional teams and drive organizational change.
• Strong analytical and problem-solving skills.

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.