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Quality Engineer 3
Pacira BioSciences San Diego, CA
$96k-114k (estimate)
Full Time | Wholesale 8 Months Ago
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Pacira BioSciences is Hiring a Quality Engineer 3 Near San Diego, CA

About PaciraPacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients.  
Each of our 3 marketed products, both in pharmaceutical and medical device, represent cutting edge technologies for pain management.  
We have 700 employees and have averaged double digit growth year over year for the past 5 years, with $500M in revenue. We are small enough for you to make your mark, and big enough for you to learn and grow!  
We have facilities in New Jersey, California and Florida. Our San Diego, CA campus is a world class manufacturing and R&D facility. We are rapidly growing and have opportunities across all of our sites and functional areas.
Why work with us?Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people. At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking – a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let’s pursue excellence together.
 
 
 
 
Summary: 
This role works closely with customer service, marketing, operations and the engineering team to provide technical product/operational support for the iovera commercial and operations team. 
Essential Duties & Responsibilities: 
The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned. 
 
  • Support Device Reliability initiatives by assessing and trending field issues and collaborating with technical teams to implement device improvement projects.
  • Develop and maintain documentation for manufacturing processes, CAPA, complaint investigations and trend analysis.
  • Develop validation protocols to support operations.
  • Support the Design and validation of test methods for evaluating product reliability.
  • Provide support and oversight for the development of procedures systems and methods for inspecting and testing of finished products.
  • Perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary. 
  • Support Supplier and internal Quality Audits.
  • Conduct or support quality event investigations (e.g., Complaints, NCMRs, Deviations, and CAPAs). Work cross functionally to help identify root cause and any necessary corrective actions. Initiate corrective actions and drive root cause analysis and resolution of issues with team members as necessary.
  •  Design Control & Product Development
  • Represent Quality and lead efforts in identifying and documenting Risk Management records (Risk Management Plans, FMEAs, Hazards Analysis).
  • Initiate product Quality Plans.
  • Represent QA in new product development projects and design changes to existing products.
  • Provide input into component and process quality requirements.
  • Write/review and approve test protocols and reports and establish sampling plans.
  • Provide input on design-for-quality efforts.
  • Support activities related to sterilization validation and biocompatibility testing.
  • Support activities related to transit validations and product shelf-life testing.
  • Process/System/Tooling and Calibration
  • Review Mfg/quality Process, system, equipment/tool and facility requirements and perform IQ/OQ/PQ as necessary.
  • Support Preventive Maintenance/Calibration activities.
Supervisory Responsibilities: 
This person has no direct supervisor responsibilities. 
 
Interaction: 
The incumbent works closely with various departments (e.g., QC, QA, Operations, regulatory and within R&D).  
Education and Experience: 
  • Bachelor’s degree in Science/Engineering or equivalent required, preferably in life sciences, biomedical
  • Experience working in FDA GMP/ISO environment required
  • Experience working in customer service and/or technical product support required
  • Must have minimum 4 years’ experience in a medical device company
 
Knowledge, Skills, and Abilities: 
 
  • Must have working knowledge of CFR 820, ISO 13485, ISO 14971, IEC 60601-01
  • Must have working knowledge of product reliability testing
  • Have working knowledge of sterilization, biocompatibility, and transit/shelf-life standards
  • Great organizational skills
Physical Demands: 
The physical demands described here are representative of those that must me met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 
Duties of this job may involve standing and/or walking, but for most part sitting for extended periods of time. Duties also involve daily keyboard data entry. 
Work Environment: 
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. 
Typical office setting with a laboratory, offices, and cubicles. Employee is required to work in the lab area and in GMP manufacturing areas. Noise level is moderate with consistent printer, telephone ringing and conversation.  
Benefits:  
  • Medical, Prescription, Dental, Vision Coverage
  • Flexible Spending Account & Health Savings Account with Company match
  • Employee Assistance Program
  • Mental Health Resources
  • Disability Coverage
  • Life insurance
  • Critical Illness and Accident Insurance
  • Legal and Identity Theft Protection
  • Pet Insurance
  • Fertility and Maternity Assistance
  • 401(k) with company match
  • Flexible Time Off (FTO) and 11 paid holidays
  • Paid Parental Leave
The base pay range for this role in California is $80,000 per year to $110,000 per year.   
The range is what we reasonably expect to pay for this role. The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications.  
 

Job Summary

JOB TYPE

Full Time

INDUSTRY

Wholesale

SALARY

$96k-114k (estimate)

POST DATE

08/12/2022

EXPIRATION DATE

04/23/2024

WEBSITE

pacira.com

HEADQUARTERS

DOWNINGTOWN, PA

SIZE

500 - 1,000

FOUNDED

2007

TYPE

Public

REVENUE

$500M - $1B

INDUSTRY

Wholesale

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Pacira Pharmaceuticals develops, commercializes, and manufactures pharmaceutical products for use in hospitals and ambulatory surgery centers.

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