Manager, Quality - Malaysia - Masimo

Masimo Malaysia

3 days ago

Full time

Description

Job Description

Job Summary:

The Quality Manager in the field of Medical Manufacturing plays a critical role in ensuring the highest standards of quality, compliance, and regulatory adherence across all aspects of the manufacturing process. This leadership position requires expertise in quality management systems, regulatory requirements, and continuous improvement methodologies. The Quality Manager is responsible for establishing and maintaining a culture of quality excellence while ensuring the safety and efficacy of medical products.

Duties & Responsibilities

Quality Management System:
Develop, implement, and manage a robust quality management system (QMS) compliant with applicable regulations such as ISO

13485 and FDA guidelines.

Ensure that all manufacturing processes and procedures adhere to the established QMS.
Regulatory Compliance:
Stay current with medical device regulations, standards, and guidelines to ensure the company's products are compliant.
Lead regulatory audits and inspections, interacting with regulatory agencies as necessary.
Collaborate with regulatory affairs to ensure timely and accurate submissions to regulatory authorities.
Quality Assurance:
Oversee and perform quality audits, assessments, and inspections to ensure adherence to quality standards.
Establish and maintain procedures for product testing, validation, and verification.
Drive continuous improvement initiatives based on quality data, feedback, and risk assessments.
Supplier Quality Management:
Manage the qualification, assessment, and auditing of suppliers to ensure the quality of incoming materials and components.
Collaborate with suppliers to address quality issues and drive corrective and preventive actions.
Risk Management:
Implement risk management processes to identify, assess, and mitigate risks associated with product quality and safety.
Ensure that risk management practices are integrated into the design and manufacturing processes.
Quality Metrics and Reporting:
Define and monitor key quality metrics to assess the effectiveness of the QMS and manufacturing processes.
Prepare regular quality reports for senior management, highlighting trends, challenges, and improvement opportunities.
Training and Development:
Provide training to employees on quality standards, regulations, and best practices.
Foster a culture of quality awareness and accountability across the organization.
Cross-Functional Collaboration:
Collaborate with R&D, manufacturing, engineering, and other departments to ensure quality considerations are integrated

throughout the product lifecycle.

Work closely with production teams to resolve quality-related issues and implement corrective actions.
Leadership and Team Management:
Lead and develop the quality team, providing guidance, mentorship, and performance evaluations.
Foster a collaborative and innovative team environment that encourages continuous learning and growth.

Minimum Qualifications

Minimum & Preferred Qualifications and Experience:

Bachelor's or master's degree in engineering, Quality Management, Life Sciences, or related field.
Extensive experience (8+ years) in quality management within the medical device or pharmaceutical manufacturing industry.
In-depth knowledge of relevant regulations and standards, such as ISO 13485, FDA QSR, and EU MDR.
Strong experience with quality tools and methodologies (e.g., Six Sigma, Lean) to drive process improvement.
Proven experience in managing and leading quality teams.
Excellent problem-solving, analytical, and decision-making skills.
Effective communication skills to interact with cross-functional teams and regulatory authorities.
Strong project management skills and the ability to manage multiple priorities.
Certification in quality management (e.g., Certified Quality Manager, Certified Quality Engineer) is a plus

Preferred Qualifications

Not applicable

Education

Bachelor's or master's degree in engineering, Quality Management, Life Sciences, or related field.

Physical requirements/Work Environment

This position primarily works in an office and manufacturing/production environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver's license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described

Quality Assurance Manager

3 days ago

Ambition Malaysia

**Job details**: · Posted 19 February 2024 · SalaryNegotiable · LocationMalaysia · Job type Permanent · DisciplineEngineering · Reference268087_ · Our client in Melaka is a leading semiconductor manufacturer. Due to rapid expansion, they are seeking a Quality Assurance Manager. ...
Clinical Quality Manager

6 days ago

ICON plc Malaysia

As a Clinical Quality Manager you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. · You will be partnering with one of our global pharmaceutical clients; a company that is advancing the development of ne ...
Quality Account Manager

3 days ago

SIG Group Malaysia

This role has several functions: · - 1) ensure a timely and appropriate response to customer complaints. · 2) any microbiological activities within the region. · 3) co-ordination of Board and Structure Changes · Key Job Functions: · - Coordination of all customer complaint invest ...
Quality Manager

1 week ago

TIME's group Malaysia Full time

Quality Manager (Packaging) - Johor Bahru · Target Recruitment Pte Ltd · Quality Assurance & Control (Manufacturing, Transport & Logistics) · Manage the Quality Control system; responsible for the overall quality within the plant · Work closely with the operations department ...
Quality Assurance Manager

3 days ago

Persolkelly Malaysia Full time

Responsibilities: · To establish plant wide Quality System and coordinating daily quality activities. · To be responsible for ISO 9001 /IATF 16949 certification and effective implementation of thesequality system. · To establish and maintain plant wide process certification syste ...
Quality Assurance Manager

2 weeks ago

Minde Group Malaysia Full time

RM 10,000 - RM 12,000 a month - Full-time · Job details · Here's how the job details align with yourprofile . Pay · RM 10,000 - RM 12,000 a month · Job type · Full-time · Shift and schedule · Monday to Friday · Location · Manage and oversee overall functions of the Qual ...
Assistant Manager, Quality Assurance

3 days ago

Malayan flour mills berhad Malaysia Full time

Job Description · To lead the overall quality assurance/control functions by effective planning, directing, controlling and following through product quality performance in the plant (including flour silo). · To ensure quality objectives and product performance are met through co ...
Quality Control Assistant Manager

3 days ago

Upright Talent Malaysia Full time

Your Roles . · Supervise lab staff, training, scheduling, and performance. · Ensure testing meets company and regulatory standards. · Implement quality control procedures for accuracy. · Analyze and communicate test results. · Maintain and calibrate lab equipment. · Manage invent ...
Quality Director

3 days ago

Ambition Malaysia

**Job details**: · Posted 19 March 2024 · SalaryNegotiable · LocationMalaysia · Job type Permanent · DisciplineEngineering · Reference272057_ · Our client is a MNC. Due to rapid expansion, they are seeking a Quality Director. · **Key Responsibilities**: · - Develop and implement ...
QA Manager

1 week ago

NodeFlair Malaysia

**Job Summary**: · **Salary** · RM13,000 - RM15,999 / Monthly · **Job Type** · **Seniority** · Manager · **Years of Experience** · Information not provided · 1. Manages projects by customer account basis covering global manufacturing sites to achieve customer-required business pe ...
Manager

6 days ago

Petrofac Malaysia

**Petrofac is a leading international service provider to the energy industry, with a diverse client portfolio including many of the world's leading energy companies.** · We design, build, manage and maintain infrastructure for our clients. We recruit, reward, and develop our peo ...
Test Lead

3 days ago

Combined Insurance Malaysia

As a Test Lead, you are expected to deliver multiple QA projects to approved scope, budget, schedule, and quality expectations with mínimal supervision. Identify and propose ways to constantly improve testing efficiency. Mentoring and coaching new/junior staff in the entire STLC ...
Operations Director

3 days ago

Ambition Malaysia

**Job details**: · Posted 19 February 2024 · SalaryNegotiable · LocationMalaysia · Job type Permanent · DisciplineEngineering · Reference268086_ · My client is a leading semiconductor manufacturer in Melaka. They are seeking an experienced and dynamic Operations Director to lead ...
Specialist, Quality Assurance

3 days ago

FFM Berhad Malaysia

**FFM FARMS SDN BHD|SG. BULOH, SELANGOR** · **Responsibilities**: · - To comply with the requirements of the documented Quality Management System that meets the ISO 9001 Standard. · - To ensure the quality management system conforms to the International Standard. · - To report on ...
Gbs - Wb - Project Delivery, Ba & Resource Mgmt

5 days ago

CIMB Group Malaysia

**Job Purpose **Key Responsibilities ** · - Overall responsibility to deliver various streams of projects/programme identified under the Programme Master Plan. · - To provide leadership to those involved in the project by defining work and ensuring deadlines are understood and ad ...
Production Manager

3 days ago

Ambition Malaysia

**Job details**: · Posted 19 February 2024 · SalaryNegotiable · LocationMalaysia · Job type Permanent · DisciplineEngineering · Reference268325_ · This global semiconductor company in Melaka is seeking a Production Manager. · **Key Responsibilities**: · - Production Planning and ...
Test Lead

3 days ago

Chubb Malaysia

As a Test Lead, you are expected to deliver multiple QA projects to approved scope, budget, schedule, and quality expectations with mínimal supervision. Identify and propose ways to constantly improve testing efficiency. Mentoring and coaching new/junior staff in the entire STLC ...
Production Technician

3 days ago

Jowat Manufacturing (SEA) Sdn Bhd Malaysia

Job Description Carry out production activities base on planning from Production Manager or planner. Ensure and properly maintain and operate the production machine and equipment in a safe manner according to SOP given. Responsible and monitor all products, conform to product qua ...
Deputy Area Commercial Manager, Commercial Banking

6 days ago

CIMB Group Malaysia

Overall performance of the Commercial Banking (CBC) including but not limited to achieving growth of the profitability of the CBC, growth of the loans/ financing portfolio by ensuring new and incremental loans / financing of the required quality are approved, accepted and disburs ...
Manager, Icimb

1 week ago

CIMB Group Malaysia

**Key Responsibilities**: · **Project Initiation** · - Develop project charter. Confirm project objective and high level scope. · - Identify key stakeholder to form a project team. Setup project steering committee and working committee. · - Assist with technical solution and busi ...