Planet Pharma
Job Description
Risk Management, Trending, Good Documentation Practices
Complaint trending, Risk document updates, Supporting Change orders
Products supported: Cannula
Target years of experience: 3-4
Technical Skills Must Have
Experience in handling complaint management
Good Technical writing skills – The candidate will write complaint summaries, investigation, and analysis summaries on the complaints.
Good communication skills
1+ years of experience in Complaint handling or customer service/technical support experience
Nice To Have
Change control of Medical Devices
Equipment Commissioning / Qualification
Process Validation
Computer System Validation (CSV)
Manufacturing, Packaging and Laboratory Equipment
Technical experience (Trouble shooting) or any similar experience or background
Quality / Process Control / Assurance of Medical Devices
3+ years of experience in the medical device industry, with a strong background in Non -Conforming Materials Reports (NCMR), CAPA, or product quality management.
Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations.
Proven experience leading NCMR and CAPA processes, ideally within a medical device or regulated industry.
Strong project management skills, with the ability to manage multiple priorities and deadlines.
Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective corrective actions.
Outstanding communication and interpersonal skills, capable of effectively working with cross-functional teams and external stakeholders.
Proficiency in Microsoft Office Suite and quality management systems (QMS). Strong technical writing capability.
Experience in Process Validation.
Responsibilities Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs. Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability. Completes risk analysis studies of new design and processes. Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes. Ensures that corrective measures meet acceptable reliability standards. Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives. May develop mathematical models to identify units, batches or processes posing excessive failure risks. As necessary, proposes changes in design or formulation to improve system and/or process reliability. May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.
Required Knowledge and Experience Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience.
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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Complaint trending, Risk document updates, Supporting Change orders
Products supported: Cannula
Target years of experience: 3-4
Technical Skills Must Have
Experience in handling complaint management
Good Technical writing skills – The candidate will write complaint summaries, investigation, and analysis summaries on the complaints.
Good communication skills
1+ years of experience in Complaint handling or customer service/technical support experience
Nice To Have
Change control of Medical Devices
Equipment Commissioning / Qualification
Process Validation
Computer System Validation (CSV)
Manufacturing, Packaging and Laboratory Equipment
Technical experience (Trouble shooting) or any similar experience or background
Quality / Process Control / Assurance of Medical Devices
3+ years of experience in the medical device industry, with a strong background in Non -Conforming Materials Reports (NCMR), CAPA, or product quality management.
Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations.
Proven experience leading NCMR and CAPA processes, ideally within a medical device or regulated industry.
Strong project management skills, with the ability to manage multiple priorities and deadlines.
Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective corrective actions.
Outstanding communication and interpersonal skills, capable of effectively working with cross-functional teams and external stakeholders.
Proficiency in Microsoft Office Suite and quality management systems (QMS). Strong technical writing capability.
Experience in Process Validation.
Responsibilities Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs. Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability. Completes risk analysis studies of new design and processes. Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes. Ensures that corrective measures meet acceptable reliability standards. Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives. May develop mathematical models to identify units, batches or processes posing excessive failure risks. As necessary, proposes changes in design or formulation to improve system and/or process reliability. May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.
Required Knowledge and Experience Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience.
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
#J-18808-Ljbffr