CAREER OPPORTUNITIES

Director, Quality Assurance

Santa Clara, CA

Full-time


This person is responsible for the development and maintenance of the quality management system that complies with the requirements of ISO 9001, ISO 13485, and the FDA QSR. The position is responsible for the translation of the Company's quality strategy into tactical policies, procedures, and processes to meet regulatory and business requirements.


Position Summary:
The Quality Assurance Director is responsible for the development and maintenance of the quality management system that complies with the requirements of ISO 9001, ISO 13485, and the FDA QSR. The position is responsible for the translation of the Company's quality strategy into tactical policies, procedures, and processes to meet regulatory and business requirements.


Regulatory:

  • *Serve as the subject matter expert for the company on compliance issues. Provide guidance and support on matters relating to FDA/FBD/ISO regulations
  • *Responsible for maintaining appropriate regulatory documents for REACH, RoHS, and Conflict Minerals requirements.
  • *Coordinate ISO/NB audits and customer audits. Coordinate FDB and/or FDA inspections if required.
  • *Support customers' regulatory compliance efforts with required records (DHR, DMR, and DHF), procedures, and history files for products built under contract.
  • *Responsible for directing the Promex Document Control function. Ensure all ECNs are reviewed for regulatory impact.

Quality Assurance Management:

  • * Manage Quality Engineers, Quality Assurance, and Quality Control activities
  • * Maintain records for customer complaints, NCMR, RMA, deviations, and CAPA.
  • * Work closely with Engineering and Operations to ensure that new processes being transferred to production meet customer and regulatory requirements.
  • * Monitor and report Key Performance Indicators (KPI's) related to company quality objectives.
  • * Plan and manage the overall activities of receiving inspection and outgoing quality functions.
  • * Ensure timely resolution of supplier failures, supplier corrective actions and preventive actions.

Quality Engineering Management:

  • * Manage the company's risk management process to ensure the appropriate risk assessment is performed and documented.
  • * In conjunction with process engineering, conduct root cause analysis and implementation of corrective action for process and customer related concerns.
  • * Possesses or can obtain an IPC-A-610 and IPC-A-600 Certified IPC Trainer certificate.
  • * Standardize inspection activities for package assembly operations using MIL-STD-883 internal and external visual requirements.

  • Education and Experience Requirements:
  • Bachelor of Science degree in Engineering; Master's degree a plus
  • Qualified (Exemplar Global) ISO 9001 / 13485 Lead Auditor is a plus
  • 10 years' experience in the medical products EMS industry

Knowledgeable in hybrid, IC packaging, and COB assembly. Familiarity with SMT operations.


  • Required experience:
  • Quality Assurance: 10 years
  • To apply, please email your resume and cover letter to Yvonne Esquer yesquer@promex-ind.com. Please include the name of the position in the subject line.




Sales Engineer

San Diego and Santa Clara, CA

Full-time


Sales Engineers will provide sales and customer service support to prospects and customers, both external and internal for microelectronic packaging and assembly services. Please visit the links below for more information.


Position Summary:
Provide sales and customer service support to prospects and customers, both external and internal for microelectronic packaging and assembly services.


Essential Duties:
The Sales Engineer will work closely with customer service, sales, engineering and manufacturing to assure that the customer requirements are accurately communicated and customer fulfillment is attained.


Other Duties & Responsibilities (Optional):
Duties and responsibilities include prospecting for new customers, assisting with marketing and trade shows. Assist with quotation generation and follow-up. May coordinate all aspects of the sales process including fiscal requirements, documentation for the order to be processed in manufacturing, communication with customer regarding schedule/delivery, order entry, shipment details, and obtaining customer feedback. Respond to customer inquiries in a timely manner. Act as liaison between the customer and manufacturing. Coordinates with cross functional teams to determine and insure on time delivery. Routinely follows up to insure customer satisfaction. Track activity, prepare and maintain records for sales leads and account status.


Minimum Qualifications:
Minimum two years proven success in a related inside sales role. An AA or BS/BA degree is desirable. The ability to work in a fast-paced environment with people with varying levels of experience and education is critical. Superb reading comprehension, attention to details and excellent verbal and written communication skills are required. Possess a solid aptitude of Microelectronic packaging and assembly. Proficient with Microsoft Suite and Outlook email. Must be able to adapt to changing needs. Prior experience with an MRP/ERP platform is required. Motivated, self-starter mindset is required.


Key Competencies:
Excellent written and oral communication skills with both internal and external customers. Ability to develop and maintain excellent customer relationships. Possess good time management skills. Ability to use common sense to solve practical problems. Ability to interpret a variety of instructions furnished in written and oral form.


Preferred Skills:
Salesforce or equivalent CRM platform experience is preferred. Prior experience working in a contract manufacturing ISO 13485, ISO 9001 and ITAR environment is preferred.


Work Environment:
While performing the duties of the job, the employee is regularly required to sit, stand and/or walk for extended periods of time; use hands and fingers; reach with hands and arms; and talk and hear. Indoors, environmentally controlled. Must be a U. S. Person authorized to work in the United States.


To apply, please email your resume and cover letter to Yvonne Esquer yesquer@promex-ind.com. Please include the name of the position in the subject line.




Director, Engineering

Santa Clara, CA

Full-time


The ideal candidate is a seasoned technology executive with expertise in the data systems and organizational methods that make operating an engineering-centric company possible. This leader and strategic thinker will set the operational tempo of the engineering group and guide the teams into using appropriate tools and systems to move quickly, add value, and grow the business.


Strategic Responsibilities:
Participate on the Executive Staff, to decide direction, methods and systems necessary to continue the growth of the business. Evaluate alternative or additional technologies to complement the core services and technologies currently available. Systematically evaluate new business opportunities and potential strategic alternatives for viability and value. Participate and add value to long term planning exercises


Tactical Responsibilities:
Manage multiple Process Development Teams, working several technical programs simultaneously to develop processes capable of assembling customer designed products. This is a high mix, Silicon Valley based microelectronic manufacturing services business (Specialized EMS). The engineering teams are tasked regularly with achieving process capability on packaging and assembly projects that are especially challenging, and have often not been tried before. Creativity, tenacity, a systematic approach with attention to detail, and a data oriented methodology are critical.


As a member of the Executive Staff, be able to:

  • * Manage customer relationships; communicating good news, bad news and technical information with comfort and clarity
  • * Evaluate business metrics and finances; Profit and loss, Revenue, Cost of Goods, material content, overhead, gross margin, Operating Income, inventory turns, assets, liabilities, return on assets, etc.

Operations comply with the basic ISO requirements, ISO 13485, are ITAR compliant and will be FDA compliant



Skills Required:

  • * Managing the engineering organization in a logical, reasoned and data driven way. Structuring projects and assignments, assigning tasks, monitoring performance, motivating individuals, improving performance, etc. Ability to teach and train the engineering resources to increase understanding and capability on a continuing basis.
  • * Ability to develop a plan to invent assembly processes that will be transferred to, and utilized by, manufacturing to produce customer products. Requires selecting specific materials (solders, epoxies, etc.), processes, fixturing, etc., building prototypes, collecting data, evaluating the results and improving the process to achieve the desired characteristics including the required quality and cost.
  • * Provide engineering support to the manufacturing departments on an ongoing basis; training operators, introducing new processes, troubleshooting when needed, updating documentation, etc.
  • * Maintain and Improve existing operating procedures and processes as well as the equipment set, standard material choices, etc.
  • * Able to work in a multicultural environment, communicate well both verbally and electronically throughout the organization as well as with customers.
  • * Requires a familiarity with microelectronic assembly processes:
  • * Technology Manufacturing in a high mix, low volume job shop environment
  • * Conventional documentation and process control procedures and methods, as well as the data tools used to manage product and production data
  • * Semiconductor wafer preparation; backgrinding and wafer sawing but not wafer fabrication.
  • * Die attach methods including stacked die, 50 micron thick die, DAF, air bridges, etc.
  • * Wire bonding, flip chip, chip scale packaging, fine pitch SMT
  • * Die packaging and overmolding of die on leadframes and substrates
  • * Surface Mount Technology
  • * Assembly characterization methods; microscopy, CSAM, XRF, metrology, mechanical measurements Data manipulation, Query and SPC methods

Background, Experience and Education:

  • * At least a BS in metallurgy, chemistry, ceramics, mechanical engineering or similar fields.
  • * Minimum of 10 years experience in microelectronic and/or electronic assembly with several years managing a group of professional engineers.
  • * Must be a US Person; a US Citizen or hold a Green Card.

Desirable:

  • * Experience with Clean room (Class 100 and up) protocols and operation.
  • * Experience in medical electronic documentation and related requirements such as pFMEA, Device History files, etc.

To apply, please email your resume and cover letter to Yvonne Esquer yesquer@promex-ind.com. Please include the name of the position in the subject line.


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