Job Description
Position: Manager Quality Assurance (Medical Devices)
Position Reports to: Senior Manager - Quality
Department: Quality
Location: Bangalore, India
Key Responsibilities
Quality Management System (QMS) & Documentation
- Manage and maintain the Quality Management System (QMS) in compliance with applicable medical device regulations and standards, including ISO 13485, 21 CFR Part 820 (QSR), MDSAP, and other regulatory requirements.
- Control, review, and approve quality system documentation, ensuring proper version control, traceability, and distribution.
- Ensure all procedures and records are updated in a controlled and compliant manner.
Regulatory Compliance & Audit Readiness
- Ensure continuous compliance with global regulatory requirements for medical devices, including USFDA, CDSCO, BSI, and other notified bodies.
- Support regulatory submissions, including preparation and review of documentation for 510(k) submissions and other market approvals.
- Act as a key point of contact during external audits and inspections, ensuring inspection readiness at all times.
- Maintain compliance with applicable standards such as ISO 13485, ISO 17025, ISO 14001, and other relevant regulations.
Internal Audits & CAPA Management
- Develop and execute the Internal Quality Audit (IQA) program to ensure compliance with regulatory and QMS requirements.
- Conduct internal audits, document findings, and ensure timely closure of non-conformities through effective CAPA.
- Track, trend, and report quality metrics and audit outcomes to management.
- Ensure effective implementation and verification of corrective and preventive actions.
Design Transfer & Design Control
- Lead and approve design transfer activities to ensure that product designs are accurately and effectively translated into manufacturing processes.
- Review and approve Design Transfer documentation, including Device Master Records (DMR), specifications, and manufacturing instructions.
- Ensure readiness of production processes, equipment qualification, and personnel training prior to transfer acceptance.
- Participate in design reviews and ensure compliance with design control requirements as per applicable regulations.
- Verify that all validation activities (process validation, cleaning validation, software validation where applicable) are completed prior to design transfer acceptance.
Manufacturing Quality Oversight
- Monitor manufacturing processes to ensure compliance with approved procedures, specifications, and validated parameters.
- Assess the impact of process changes, validations, and design modifications on product quality and regulatory compliance.
- Support change control processes and ensure appropriate approvals and documentation.
Product Release & Batch Review
- Review Device History Records (DHR) for completeness and compliance prior to product release.
- Approve Certificates of Analysis (CoA) and authorize final product release and distribution.
- Review incoming material inspection results and oversee Material Review Board (MRB) activities.
Laboratory & Testing Management
- Oversee laboratory operations in compliance with ISO 17025 and applicable regulatory requirements.
- Ensure accuracy, integrity, and traceability of test results.
- Manage internal and external testing activities, including inter-laboratory comparisons and validation of test methods.
- Ensure calibration, maintenance, and qualification of laboratory equipment.
Customer Complaints & Post-Market Surveillance
- Manage investigation, root cause analysis, and resolution of customer complaints in accordance with regulatory requirements.
- Ensure timely reporting of adverse events where required.
- Oversee post-market surveillance activities, including trend analysis and feedback integration into the QMS.
Supplier & External Coordination
- Coordinate with suppliers, external laboratories, and inspection agencies to ensure compliance with quality requirements.
- Review external test results and ensure alignment with internal quality standards.
- Support supplier quality management and qualification processes.
Management Review & Continuous Improvement
- Support Management Review Meetings (MRM) by compiling and presenting quality data and performance metrics.
- Drive continuous improvement initiatives and implementation of best practices across quality and manufacturing processes.
- Monitor and achieve Quality and Laboratory KPIs.
Environmental, Health & Safety (EHS)
- Ensure compliance with Environmental, Health & Safety regulations and internal policies, including ISO 14001 requirements.
- Promote safe work practices and ensure reporting and investigation of incidents, near misses, and hazards.
- Support risk assessments, environmental impact analysis, and workplace safety initiatives.
Additional Responsibilities
- Ensure confidentiality of all product, regulatory, and laboratory data.
- Act as a delegate for Senior Manager Quality or Manager QC when required.
- Ensure timely completion of scheduled activities such as calibration, validation, audits, and CAPA closure.
- Perform other duties as assigned in line with business and regulatory requirements.
Note
This job description may be modified by management to meet evolving regulatory and business requirements.
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.
