Job Archives

Posted 5 months ago

Position Title:           Quality Engineer

Functional Group:   Quality Assurance, Production, Materials, Manufacture Engineering

Report To:                 VP of Quality Assurance

PURPOSE OF POSITION:  The Quality Engineer will be responsible for creating, updating, and maintaining quality system documents and records.  The position will be expected to review, approve, and implement changes to quality system records produced by document control, material control, product development, production, and incoming inspection.     

MAJOR DUTIES AND RESPONSIBILITIES:

  • Trains and supports all associates on product processes and procedures.
  • Proactively report project activities, issues, and schedule to management.
  • Control of quality system records, revisions, including accurate and timely storage/retrieval.
  • Control of the distribution and accuracy of all the documents used in Product Development, Production, and Quality Assurance. 
  • Supervises Quality Control and Production personnel data collection and entry into Quality System reports.  
  • Assist in the writing and execution of qualification procedures for tools and fixtures used in manufacturing.
  • Responsible for the preparation of product for sterilization and the review and final release of product post sterilization. 
  • Responsible for coordination of LAL, Bioburden, dose audits, EO residual testing and revalidation requirements for sterilized products.  
  • Supervises the timely processing of complaints, nonconformity (MRR), returned goods and Corrective and Preventive Action (CAPA) activities including the processing, database management and data trending. 
  • Supervise incoming inspection, finish good inspections and final product release for distribution.
  • Display working knowledge of the proper use of hand tools, simple power tools, and basic electronics.
  • Provide feedback and verification of assembly and process testing procedures. 
  • Perform occasional lifting of up to 50 pounds for inventory and equipment relocation. 

EDUCATION / EXPERIENCE REQUIREMENTS:

  • Preferred undergraduate degree or related degree required in related discipline industry experience.
  • Minimum of 5 years combined experience in medical device quality and regulatory systems. 

OTHER QUALIFICATIONS:

  • Experience working within medical device quality systems including Quality System Regulation (QSR) and ISO 13485:2016.
  • Knowledge of and/or experience with the Medical Device Directive desirable.
  • Must be detail oriented, an effective communicator, and able to lead members of multiple disciplines within a team environment.
  • Good technical writing skills.
  • Strong computer skills, including Word and Excel
  • Detail-oriented and strong organization skills

The Quality Engineer will be responsible for creating, updating, and maintaining quality system documents and records.  The position will be expected to review, approve, and implement changes to qua...

Posted 6 months ago

Position Title:                Operations Project Manager

Functional Group:           Operations

Reports To:                      Director of Operations

Employment Status:       Full Time, Exempt

PURPOSE OF POSITION:  The Operations Project Manager plays a pivotal role in managing client relationships, generating project key performance indicators, and supporting production planning to ensure seamless operational execution. Responsibilities include but are not limited to project plan creation, purchase order (PO) tracking, and scheduling of product builds to meet client forecasts. 

MAJOR DUTIES AND RESPONSIBILITIES:

  • Collaborate with Operations Leadership to establish projects which align with client objectives.
  • Establish project plans, tasks, resources, and ownership to ensure production milestones are met.
  • Manage internal and external projects which may extend to suppliers. 
  • Proactively work to remove project obstacles, identify and manage issue escalations, and provide support to teams balancing competing priorities.
  • Collaborate with New Product Introduction (NPI) Project Managers and Leadership to drive enhancements of project management processes, tooling and templates to improve execution and efficiency.
  • Identify and manage costs associated with project budgets and Client price models.
  • Plan, schedule, and coordinate production of client products.
  • Collaborate with Buyer/Planner, Controller, and Operations Leadership to ensure materials and equipment are in place for production.
  • Report on production status and production issues to Leadership Teams
  • Complete other engineering duties as assigned and provide support for other functional groups, as necessary.
  • Contribute to the Operations operating system to continuously improve associate development, data analysis, issue resolutions, core processes, and effective team meetings.

MINIMUM REQUIREMENTS:  

  • Engineering (BSME, BSEE, BSBE, etc.) degree required.
  • Project Management Professional (PMP) certification preferred.
  • Minimum 6-8 years’ experience in medical device manufacturing or contract manufacturing.
  • Significant experience with FDA GMP and ISO 13485.
  • Proven professional qualities, including strong initiative, integrity, and the desire/ability to work and grow in a dynamic team environment.
  • Proven history of being able to consistently promote a positive, professional atmosphere and support activities that enhance the welfare and morale of PLS associates even during periods of shifting priorities.
  • Proven problem solver with excellent track record of providing effective solutions based on data analysis and building strong relationships with key stakeholders.
  • Ability to perform work with low to medium supervision/direction.
  • Highly experienced user of Microsoft Office Suite to create documentation, spreadsheets, and databases to support Manufacturing operations.
  • Excellent written and oral communication skills with excellent attention to detail.
  • Ability to organize and manage multiple projects simultaneously.
  • Experience with both low complexity/high volume and high complexity/low volume production both in and out of ISO Class 7/8 Cleanrooms preferred.

The Operations Project Manager plays a pivotal role in managing client relationships, generating project key performance indicators, and supporting production planning to ensure seamless operational e...

Posted 6 months ago

Position Title: Production Assembler
Functional Group: Manufacturing Engineering, Production, and Materials
Reports To: VP of Operations
Employment Status: Full Time, Exempt

PURPOSE OF POSITION: 

The Production Assembler will be responsible for assembling high quality medical devices and product packaging according to established manufacturing procedures in a clean room environment.

MAJOR DUTIES AND RESPONSIBILITIES:

  • Assemble/rework and package high quality electromechanical/disposable medical devices and tools according to established manufacturing procedures.
  • Support material control and management per established procedures and SOP’s.
  • Support the development of manufacturing processes and provide feedback to improve production efficiencies.
  • Support incoming inspection, finish good inspections and final product release for distribution.
  • Perform cleaning of product and clean room environment per established procedures and SOP’s.
  • Provide feedback and verification of assembly and testing procedures.
  • Perform occasional lifting of up to 30 pounds for inventory and equipment relocation.
  • Display working knowledge of the proper use of hand tools, simple power tools, and basic electronics.
  • Support development of methods for effective use of in-house test and production fixturing.
  • Maintain a clean and organized work area to facilitate manufacturing functions.
  • Generate accurate production records on a consistent basis.
  • Interpret assembly drawings and perform data entry either written or via computer.
  • Support quality assurance with production report review, manufacturing process auditing, and collection ofproduction data for analysis as needed.
  • Provide hands on job function training to coworkers as needed.
  • Notify the supervisor of any production abnormality or unsafe conditions and practices.
  • Perform other duties as requested.

MINIMUM REQUIREMENTS:

  • High school degree, Technical/Vocational school, or equivalent experience in a similar position
  • 1-3 years in a commercially regulated medical manufacturing environment. Technical training may be applied in lieu of experience.
  • Ability to consistently demonstrate a positive, professional attitude which will support activities that enhance the welfare and morale of fellow employees even during periods of shifting priorities.
  • Good verbal skills with the able to read, write and speak in English required
  • Ability to take and follow specific direction(s) without deviation regarding production of medical devices required.
  • Ability to execute repetitive tasks for extended periods of time with minimal mistakes or errors.
  • Experience working within medical device quality systems (cGMP) including Quality System Regulation (QSR) and ISO 13485 preferred
  • Good computer skills for data entry preferred.
  • Soldering/IPC training and/or experience desired.
  • Knowledge of ESD practices desired.
  • Experience with Microsoft Office (Word, Excel, Outlook) desired.
  • Cleanroom production experience desired.

The Production Assembler will be responsible for assembling high quality medical devices and product packaging according to established manufacturing procedures in a clean room environment.