- Performing in-process and final product review of documents for accurate format, signatures, dating and Good Documentation Practices (GMP) for commercial and clinical product in a timely matter.
- Maintain compliance with operating procedures and ensure training is completed prior to the operation of a task.
- Ensure all documentation is legible, complete, and correct per current Good Manufacturing Practices Inspect labeling for the finished product.
- Understand and perform line clearance activities in manufacturing.
- Perform in-process quality audits in manufacturing to assure compliance to manufacturing documentation and good documentation practices.
- Initiate and assist with the NCMR process during manufacturing of commercial and clinical product.
- Demonstrate good computer skills and perform computer operations to generate reports and graphs using Microsoft Word and Excel.
- Perform in-process product inspection and testing for commercial and clinical product.
- Must be able to distinguish between certain colors
- Familiarize yourself with the manufacturing processes.
- Review shipping documentation to assure accurate order shipment.
- Provide training for new employees
- Takes on new challenges and expanding roles to assist with growing demands within different areas of the Quality Department.
- Must have strong organization skills and attention to detail
- Assumes and performs other duties as assigned.
- Typically requires a high school certificate (SPM) or Diploma in any field or equivalent with minimum 2 years of relevant industry experience and/or training.
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required.
- Experience using computer
- Ability to understand and perform job per documents instructions in English
- Good interpersonal and teamwork skills.
- Must be able to flex schedule to work in different shifts to meet demand.
- Quality Assurance and/or QA/QC experience.
- Min 2 years in the medical device industry or manufacturing industry previous experience.
- Ideally has experience working with the following: Agile, Oracle and/or Camstar software programs.
- High school certificate (SPM) or Diploma in any field or equivalent.
-
QC Inspector 3
Found in: Talent MY C2 - 3 days ago
Dexcom George Town, MalaysiaAbout Dexcom · Founded in , Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming di ...
-
QA Inspector 2
Found in: Talent MY C2 - 3 days ago
Dexcom George Town, MalaysiaAbout Dexcom · Founded in , Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming di ...
-
IQA/FG Inspector
Found in: Talent MY C2 - 3 days ago
Boston Scientific George Town, MalaysiaPurpose Statement: · Under normal supervision of the area lead, performs moderately complex visual, electrical and mechanical inspections of BSC purchased materials and components for first article and routine inspections. · Key Responsibilities: · • Make acceptance or rejection ...
-
Ventilation Inspector
Found in: Foundit MY A2 - 2 days ago
JLL Penang, Bayan, Malaysia Full timeWhat this job involves: · Greasing the wheels of day-to-day operations · You will be involved in the overall upkeep of plant and facilities equipment to ensure smooth daily operations. To do this, you'll need to regularly inspect all equipment rooms and other facilities, and take ...
-
Real Estate Broker
Found in: Foundit MY A2 - 2 days ago
J.e.s Advisory Sdn bhd Penang, Malaysia Full timeJob Responsibility · Offer guidance and assist sellers and buyers in marketing and purchasing property for the right price under the best terms. · Determine clients' needs and financials abilities to propose solutions that suit them. · Intermediate negotiation processes, consult ...
-
Manufacturing Associate 4
Found in: Foundit MY A2 - 5 days ago
Dexcom Penang, Malaysia Full timeAbout Dexcom · Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transformin ...
-
Staff QA Engineer
Found in: Foundit MY A2 - 2 days ago
Dexcom Penang, Malaysia Full timeAbout Dexcom · Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transformin ...
-
Process technician
Found in: beBee S2 MY - 3 days ago
Bosch Pulau Pinang, Malaysia Full timeJob Description To assist Manufacturing Engineering document: Visual aids, work instructions, 5 S photo, Safety, Inspector Work Sequence. To assist in preparing monthly VQ awareness presentation material for briefing purpose Daily complaint of raw material to PUQ and assist in sc ...
-
Engineer II
Found in: Foundit MY A2 - 2 days ago
Ultra Clean Technology Batu, Penang, Malaysia Full timeJoin UCT and be part of the fastest-growing sector in the world We indirectly touch every semiconductor chip that goes into every smartphone, smart car and device that uses artificial intelligence. This is a critical time for the semiconductor industry and for UCT - as technology ...
-
Quality Auditor
Found in: Foundit MY A2 - 2 days ago
Intersurgical Medical Sdn Bhd Simpang, Penang, Malaysia Full timeJob Responsibility · The QC Inspector performs a sampling inspection of the product and releases the product on a timely basis.Verify the information provided on the packing list with physical count to ensure incoming accuracy. · Performs an inspection of incoming raw materials a ...
QA Inspector 2 - Penang, Malaysia - Dexcom
Description
About DexcomFounded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and healthcare professionals better manage diabetes. Since the company's inception, Dexcom has focused on better outcomes for patients, caregivers, and clinicians by delivering solutions that are best in class - while empowering the community to take control of diabetes. Dexcom reported full-year 2022 revenues of $2.9B, a growth of 18% over 2021. Headquartered in San Diego, California, with additional offices in the Americas, Europe, and Asia Pacific, the company employs over 8,000 people worldwide.
Summary
As a member of the QA Lot Release team, the inspector is responsible to ensure the activities related to the inspection functions in a manner which meets company standards and methods as determined by quality assurance or other engineering departments.
Performs inspections, checks testing and sampling procedures for product manufacturing processes. Carries out packaging line, manufacturing inspections and sampling and testing of in-process and Lot Release to ensure that company standards are met. Monitors critical equipment and instrumentation. May apply approval or rejection labels to lot/product once analytical data is evaluated.
Essential Duties And Responsibilities
