QA Operations Manager

Molnlycke Health Care • United States, United States • 11h ago

Take your impact further

We are now looking for a QA Operations Manager to lead quality management and governance across site operations, ensuring full compliance with regulatory and quality system requirements (e.g., ISO13485, MDSAP, FDA, EU MDR). The role oversees packaging quality processes, product release, and laboratory testing, while building a competent and compliant team. It also supports manufacturing sites (KK/KM/KH) in resolving quality issues through root cause analysis and preventive actions and ensures effective quality control plans are in place to consistently meet product, customer, and regulatory standards.

Where You'll Make a Difference

In this role, you'll contribute to meaningful work that improves lives. ? You ' ll collaborate across teams, bring your ideas to the table, and help shape solutions that matter. ? Whether you ' re streamlining a process, launching a product, or supporting a colleague, you ' ll be making a difference every day.

Here's how you'll make an impact in this role:

Manage routine QA activities within operation areas for all sites (Kuala Ketil / Kulim / Kulim Hi-Tech).

Responsible over testing and final releasing of products.

Support and assisting manufacturing in quality and regulatory requirement across all manufacturing sites (Kuala Ketil / Kulim / Kulim Hi-Tech).

Production & Process Controls - review, change and approve manufacturing procedures, test method validations, quality inspection plans, and other quality documentations as required.

Nonconformance (NC) and CAPA processing - Lead quality activities such as inspection methods, NC containment, correction, closure and CAPA, and drive improvement through analysis of trend data for all sites ((Kuala Ketil / Kulim / Kulim Hi-Tech). Ensure NC and CAPA completed before due date.

Auditing - routinely perform internal and process-related audits (Gemba walk) to monitor the effectiveness of implemented corrective actions. Responsible to Implement and conduct line process audit.

Support all external, regulatory and notified body audits as lead auditee for all QA operations areas of responsibility, across all Gloves manufacturing sites.

Support Quality System team in product complaint investigations.

New artwork and new packaging sample approval.

New supplier assessment on packaging materials.

Establish and maintain in-house technical requirements for packaging materials.

Supervise incoming packaging material inspection, physical laboratory testing activities and QA Lot Release testing and issue lot release certificate.

Responsible to drive site level quality improvement programs, projects or initiatives which would result in cost improvements, efficiency improvement and workforce optimisations.

Leading cross-functional quality related review and discussions associates with product quality, complaints, driving resolutions to the issues identified.

Supervise the filing, scanning & verification and archiving the finished products lot records.

Specific responsibilities with respect to ISO/IEC 17025 accredited testing for natural rubber and synthetic rubber surgical gloves / examination gloves, tested in accordance to specifications ASTM D3577, ASTM D3578, and ISO 10282:-

Tensile Properties Test according to ASTM D412, EN 455-2 and ISO 37.

Ageing Test according to ASTM D573 and ISO 188.

Water tightness Test for Detection of Holes according to ASTM D5151 and EN 455-1.

Preparation and conditioning of test pieces for physical test methods according to ISO 23529.

What you'll need:

Degree in Engineering or major science equivalent

5 years of direct working experience in Quality Assurance (QA) functions in medical industries

Knowledge of Total Quality Management, Sampling Plan & AQL Quality Auditing, Statistical Quality Control and Probability are necessary.

Knowledge on in-depth tensile properties testing and Water tightness Test for Detection Of Holes techniques.

Experience with ISO/IEC 17025 accredited laboratory environment.

Knowledge on method validation and evaluation of measurement uncertainty.

Knowledge of QSR, CFR, cGMP, and ISO regulations (required)

Capabilities

Analytical and strategic skills.

Regulatory requirements & standards for medical devices.

Product / Material knowledge.

Management/Managing skills.

Test methodology knowledge.

Problem solving / analytical skills.

Interpersonal and supervisory skills.

Our approach to Diversity & Inclusion

We're building a workplace where everyone feels seen, heard, and valued. We believe that a diverse mix of people (from different cultures, ages, geographies, and genders) makes us stronger. It brings fresh perspectives, drives better decisions, and helps us deliver solutions that reflect the world we serve.

Inclusion isn't just a value, it's how we work, grow, and lead together.

About Mölnlycke

Mölnlycke is a world-leading medical products and solutions company that equips healthcare professionals to achieve the best patient, clinical and economic outcomes.

Our business is organised in the four business areas Wound Care, Operating Room Solutions, Gloves and Antiseptics, where customer centricity, sustainability and digitalisation are at the heart of everything we do.

Mölnlycke employs around 8,700 people. The company headquarters are in Gothenburg, Sweden and we operate in more than 100 countries worldwide. Mölnlycke is a founding partner of GoCo Health Innovation City, a world-class innovation cluster for health.

Since 2007, the company has been part of Investor AB, an engaged owner of high-quality, global companies which was founded by the Wallenberg family in 1916. For more information, please visit www.molnlycke.com and www.molnlycke.com/careers

Information at a Glance

Apply now

Req ID: 9993

Posting Start Date: 25/05/2026

Working Location:

Category: Quality and Regulatory

Function: COO & Sustainability

Job Posting Location: Malaysia Kuala Ketil Fact Site

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