Manager - Quality Engineering

Position: Manager – Quality Engineering Quality engineering manager is responsible for measuring and communicating quality performance of all key manufacturing sites for existing and new products. The role supports QA of all manufacturing sites ensuring high product quality, smooth operations. The role leads the planning, development, implementation, communication and maintenance of a company's quality performance. Defines quality goals, monitor performance for all key product manufacturing sites and key products utilizing using statistical and analytical tools and methods. Applies monitoring of performance through score cards, trend analysis and identify areas of continuous improvement initiatives. Analyses data by completing hypothesis, normal distribution, and process capability analysis tests. Analysis of current quality plans, harmonization and recommendation on simplification / effectiveness improvement. Improves quality plans by identifying evolving / new critical control points and implementing preventive measures, understanding equipment or process limits, monitoring production inspection results, and verifying quality procedures. New Product implementation. Coordinates with cross-functional teams including R&D, Manufacturing, and Quality Assurance to establish priorities and goals for design and development projects, risk management, failure analysis, process validation, product capability, trend analysis, and statistical process controls. Inputs to manufacturing teams on how to enhance product manufacturability and reduce reject costs with new process or new product implementation. Minimum Bachelor's Degree (Master Degree is a plus) Engineering and Science (Chemistry/material/polymer science/engineering) or relevant discipline. Job Experience ~ Minimum 4 to 5 years working experience in medical devices or pharmaceutical products. Experience in QC/QA function in manufacturing set up is desired. Basic practical and theoretical/fundamental understanding of batch manufacturing processes in polymer or latex industry. In-depth knowledge of quality principles, concepts, industry practise and standards. Strong project management and process improvement skills Knowledge of Six-Sigma, DMAIC (Define, measure, analyse, improve and control) methodology, performance measures and quality improvement statistical tools are preferred. Knowledge of ISO 14971 Risk management tools (Hazard analysis, failure mode analysis) and ISO 13485 is preferred. Competent in systematic data analysis including use of more advanced statistical tools followed by presentation of results. Great attention to detail and problem-solving abilities while managing multiple tasks and projects with prioritization and meet timelines. Good to communication including written and spoken English skills and interpersonal skills. Excellent skills in data analysis and usage of MS office tools is must to have. Ability to understand and mitigate risks or implications from outcome of activities and decisions made and take accountability and responsibility 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. 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 , 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. 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. Our business foundation is strong, among our values are Integrity and Respect, our people are highly engaged, and we are excited about a new phase in the company history. We have a focus on safety and teamwork - and we want you to join us 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.