We are an ISO 13485 certified manufacturer of thermoformed plastics serving the medical and food industries. We welcome dedicated, hardworking individuals to join our team. Our long-term employees take pride in performing their duties while meeting our corporate objectives. Our goal is to provide a safe, welcoming and productive workplace for our current and future coworkers.
The Regulatory Affairs Specialist coordinates and documents internal regulatory processes, such as internal audits, inspections, validation activities, license renewals, or registrations. The Regulatory Affairs Specialist also communicates at the highest level with our customers and other regulatory professionals and consults to our team to assure our service to the customers always complies. We hope to lead and guide our customers to help them stay in compliance.
Responsibilities
- Create required documents for international submission purposes (ISO 13485, ISO
14001, CA Green Business, Sustainability, etc.)
- Maintain records and documents that support regulatory requirements and activities
- Regulatory Affairs Subject Matter Expert (SME)
- Remain current on Global Regulations and Standards; provide RA leadership
- Monitor impact of changing regulations
- Advise upper management on current and emerging regulatory requirements and how
to satisfy those requirements
- Ensure that the company's Quality System is compliant with the relevant current
regulations
- Create, update, and review SOPs and Work Instructions for accuracy
- Participate in regulatory inspections/audits by internal and external audit authorities
- Issue Non-Conformances
- ISO Audits (Recertification and Surveillance Audits)
- Issue CAPAs to improve the organizations processes
- Ensure that the company's Quality System is compliant with the relevant current
medical device regulations
- Further responsibilities include support of the Engineering and Quality teams, providing
guidance and serving as a resource in the development and implementation of product
development, CAPA, internal audit and vendor/supplier audit programs, process and
product validation.
Qualifications
- 1-3 years in an ISO and FDA-regulated environment (GMP, MDR, QSR, ISO 13485, ISO 9001,
ISO 14001)
- 3+ years of professional Quality experience
- Regulatory Affairs Certification (RAC) by the Regulatory Affairs Certification Board (RACB)
desired
- Bachelor of Science Degree in Plastics, Industrial, Mechanical, Chemical Engineering or
equivalent
Job Types
Full-time
Salary
$80,000.00 - $95,000.00 per year
Benefits
- 401(k)
- Dental Insurance
- Health insurance
- Life insurance
- Paid time off
- Referral program
- Retirement Plan
- Vision insurance
Schedule
- 8-hour day shift
Ability to commute/relocate
Burlingame, CA: Reliably commute or planning to relocate before starting work (Required)
Experience
Manufacturing: 1 year (Preferred)
Shift availability
Night Shift (Preferred)
Language
English (Required)
Are you looking for full-time employment? Do you have a mechanical aptitude? Due to retirements and continued growth, Merrill’s Packaging is seeking machine operators for our plastic thermoforming manufacturing business. We have been in business over 60 years in Burlingame California providing packaging for the medical, food, electronic and horticulture industries. As a valued member of our production team, you will interface with our designers, toolmakers, production schedulers and the quality team while meeting the needs of our customers. We provide in-house training and promotional opportunities. To schedule your
interview, call us at 800-284-5910.
We are hiring immediately. No experience needed. We will train you. Hiring bonus of $1,000 will be paid after your first 180 days!
Responsibilities
Qualifications
Benefits
Schedule
Supplemental pay type
Signing bonus
Ability to commute/relocate
Burlingame, CA: Reliably commute or planning to relocate before starting work (Required)
Language
English (Required)
Are you looking for full-time employment? Do you have a mechanical aptitude? Due to retirements and continued growth, Merrill’s Packaging is seeking machine operators for our plastic thermoforming manufacturing business.
We have been in business over 60 years in Burlingame California providing packaging for the medical, food, electronic and horticulture industries. As a valued member of our production team, you will interface with our designers, toolmakers, production schedulers and quality team while meeting the needs of our customers.
We provide in-house training and promotional opportunities.
To schedule your interview, call us at 800-284-5910. We are hiring immediately.
No experience needed. We will train you!
Job Types
Full-time, Temporary
Salary
$20.00 - $25.00 per hour
Benefits
- 401(k)
- Dental insurance
- Health insurance
- Vision Insurance
- Life insurance
- Paid time off
- Referral program
- Retirement Plan
Schedule
8-hour day shift
Ability to commute/relocate
Burlingame, CA: Reliably commute or planning to relocate before starting work (Required)
Language
English (Required)
We are a manufacturer of thermoformed plastics serving the medical and food industries. As a member of our tooling team, you will be expected to become familiar with all aspects of
thermoform tool development and repair. We welcome dedicated, hardworking individuals to join our team. Our long-term employees take pride in performing their duties while meeting our corporate objectives. Our goal is to provide a safe, welcoming and productive workplace for our current and future coworkers. We offer in-house training and promotion to selected personnel.
Responsibilities
- Supporting ISO 13485, GMP, Green Certification, and 5-S programs
- Embracing a “Safety First” culture
- Read and understand written work instructions
- Use basic hand tools, powered and manual shop equipment such as band saw, belt
sander, drill press, manual lathe and mill
- Basic knowledge and understanding of common measuring instruments and engineering
drawings
- Ability to program CNC machining centers
- Set up and operate CNC machining centers to produce tooling components
- Measure and inspect machined parts to confirm conformance to specification
- Assist in tool preparation as needed to ensure production needs are fulfilled
- Assist in back drilling, polishing of molds, and cutting die preparation as needed
- Documentation of work completed
- Basic maintenance of equipment
- Maintain a clean and safe work environment
- Ability to work well in small teams
- Perform other duties as assigned or directed
Qualifications
- Must have a minimum of three years’ experience working in a machine shop environment
- Must pass skills testing with a minimum of 80%
- Excellent communication, mechanical, math and organizational skills
- Haas, Fadal, GibbsCAM experience preferred
- Ability to work on feet and carry objects weighing up to 50 lbs
- Classes and/or degree in machining and/or a related field a plus
Job Types
Full-time, Temporary
Salary
$20.00 - $25.00 per hour
Benefits
- 401(k)
- Dental insurance
- Health insurance
- Vision Insurance
- Life insurance
- Paid time off
- Referral program
- Retirement Plan
Schedule
8-hour day shift
Ability to commute/relocate
Burlingame, CA: Reliably commute or planning to relocate before starting work (Required)
Language
English (Required)
We are an ISO 13485 certified manufacturer of thermoformed plastics serving the medical and food industries. We welcome dedicated, hardworking individuals to join our team.
Our long-term employees take pride in performing their duties while meeting our corporate objectives. Our goal is to provide a safe, welcoming and productive workplace for our current and future coworkers.
Duties and Responsibilities include:
We are a manufacturer of thermoformed plastics serving the medical and food industries. As a member of our tooling team, you will be expected to become familiar with all aspects of thermoform tool development and repair. We welcome dedicated, hardworking individuals to join our team. Our long-term employees take pride in performing their duties while meeting our corporate objectives. Our goal is to provide a safe, welcoming and productive workplace for our current and future coworkers. We offer in-house training and promotion to selected personnel.
Responsibilities
- Supporting ISO 13485, GMP, Green Certification, and 5-S programs
- Embracing a “Safety First” culture
- Promoting teamwork at all times (leads, motivates, and sets goals)
- Scheduling, conducting and documenting safety meetings
- Communicates company policy
- Create job packets
- Create and ensure that job packets and procedures are followed by packers and
material handlers
- Reviews and reports attendance concerns for packers and material
handlers
- Supply staff performance details for reviews
- Daily assignment of tasks to keep productivity within company standards
- Train new employees
- Supervise Inspector/Packer training program
- Request materials for timely start-up
- Participate in production planning meetings
- Assigns breaks and lunch covering when necessary
- Evaluates production reports for accuracy
- Complete job summaries
- Production department cleanliness and organization
- Resource planning including; determining manpower, equipment, tooling, raw materials
needed to ensure the job starts as scheduled
- Completes NCR’s to analyze jobs not meeting yield and/or productivity goals
- Complete the SO Travel and approve accuracy
- Evaluate and report production efficiency, back log, machine hours, late orders, quality
performance, customer feedback and on time record.
- Reviews work instructions for accuracy
- Participates in brainstorming sessions and cross-departmental meetings to ensure
collaboration and cohesiveness
Qualifications
- High school diploma/GED required
- Bachelor's Degree in a related field a plus
- Strong work ethic, math, computer, communication and organizational skills
- Must have a minimum of three years’ experience in a production environment
- Previous experience in a supervisory capacity
Job Types
Full-time
Salary
$60,000.00 - $78,000.00 per year
Benefits
- 401(k)
- Dental Insurance
- Health insurance
- Life insurance
- Paid time off
- Referral program
- Vision insurance
Schedule
- 8-hour day shift
- Evening shift
- Monday to Friday
Ability to commute/relocate
Burlingame, CA: Reliably commute or planning to relocate before starting work (Required)
Experience
Manufacturing: 1 year (Preferred)
Shift availability
Night Shift (Preferred)
Language
English (Required)
We are a manufacturer of thermoformed plastics serving the medical and food industries. As a
member of our tooling team, you will be expected to become familiar with all aspects of
thermoform tool development and repair. We welcome dedicated, hardworking individuals to
join our team. Our long-term employees take pride in performing their duties while meeting
our corporate objectives. Our goal is to provide a safe, welcoming and productive workplace
for our current and future coworkers. We offer in house training and promotion to selected
personnel.
Responsibilities
- Embrace a “Safety First” culture
- Support ISO 13485, GMP, green certification and 5-S programs
- Read and understand work instructions
- Pick thermoformed parts from production web
- Physical and visual inspection of product is required to detect non-conforming product
- Correctly reports all quality defects to the appropriate team members
- Establish and maintain high standards for quality, housekeeping and productivity
- Complete production reports as instructed
- Interact and maintain positive relationships with all levels of leadership
- Accomplish special projects and other assignments/duties as required by management
- Regular and predictable attendance is an essential function of the job
- Ability to work effectively in small teams.
Job Types
Full-time, Temporary
Salary
$18.75 - $19.25 per hour
Benefits
- 401(k)
- Dental insurance
- Health insurance
- Vision Insurance
- Life insurance
- Paid time off
- Referral program
- Retirement Plan
Schedule
8-hour day shift
Ability to commute/relocate
Burlingame, CA: Reliably commute or planning to relocate before starting work (Required)
Language
English (Required)
