Quality Assurance Manager

 

Position: Quality Assurance Manager 

Reports to: President/ CEO 

Status: Full-time / exempt 

Location: Rancho Bernardo 

 

ABOUT MICROTEK: 

Microtek is a microelectronic manufacturing company, established in 2015. Microtek’s vision is to deliver novel life sciences services, devices, and therapeutics to provide equitable access and a meaningful connection to healthcare. We provide innovative product development by incorporating microelectronics manufacturing, engineering, bioscience, and pharmaceutical strategies.  We use state-of-the-art equipment and procedures to discover new chemical entities (NCEs) or new biological entities (NBEs) with therapeutic potential, for integration into our microelectronic technologies. 

 

WHO SHOULD APPLY: 

We are seeking a quality assurance manager to build and execute a strategic approach towards assuring consistent quality of production by developing and enforcing good, automated manufacturing practice (GAMP) systems; validating processes; providing documentation and managing staff. Our ideal candidate can think big- helping to develop our infrastructure, while also acting on improving upon our operational systems.  

 

This position is perfect for you if you enjoy creating something from the ground up and taking ownership of your projects and department; you’re comfortable with ambiguity and love a challenge. You’re comfortable working in a startup, small business environment. You’re the type of person who can build a roadmap for innovative and highly promising strategies, laying out the when, where, and how.  

 

PRIMARY RESPONSIBILITIES: 

  • Accomplish quality assurance objectives by training, assigning, scheduling, coaching, counseling, and disciplining employees; communicating job expectations; planning, monitoring, appraising, and reviewing job contributions; planning and reviewing compensation actions; enforcing policies and procedures.  

  • Achieve quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change.  

  • Develop quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories.  

  • Validate quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures.  

  • Maintain and improve product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop new product and engineering designs, and manufacturing and training methods.  

  • Prepare quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.  

 

DESIRED QUALIFICATIONS AND COMPETENCIES: 

  • Minimum 5 years QA experience in: Process Improvement, Analyzing Information, Strategic Planning, Verbal Communication, Informing Others, Quality Engineering, Emphasizing Excellence, Attention to Detail, Thoroughness, Dealing with Complexity 

  • BS degree  

  • Proficiency with Microsoft Office, Word and Excel 

  • Ability to read, comprehend and write in English 

  • Strong verbal and written communication skills 

  • Ability to successfully assess personnel strengths, weaknesses and establish guidelines for improvement 

  • Ability to successfully interface with other Company departments, in particular Sales, Engineering, Purchasing and Quality Assurance 

  • Strong organizational skills, including recordkeeping and the ability to meet established timelines and due dates 

 

PREFERRED SKILLS AND ABILITIES: 

  • Leadership and coordination skills 

  • Manufacturing supervisory experience, preferably in a microelectronics assembly environment 

  • Flexible and organized. Able to plan and organize activities accordingly and handle various tasks simultaneously. 

  • Decision making skills and ability to work independently in a start-up environment 

  • Due to small business environment, must be able to assume responsibilities beyond scope of job description 

  • Knowledge of ISO 9001 and/or ISO 13485 a major plus 

 

COMPENSATION: 

This is a full-time role with an annual salary based on level of experience and education. This position includes company standard benefits: 

 

  • 401k retirement plan with 5% employer match and immediate vesting 

  • Access to health/dental/vision plan 

  • Accidental death and dismemberment and disability insurance  

  • 10 paid holidays 

 

EQUAL OPPORTUNITY EMPLOYER:  

Microtek is an equal opportunity employer.  We encourage all qualified candidates to apply, regardless of race, color, creed, religion, national origin, gender, disability, age, veteran status, sexual orientation, gender identity or expression, genetic information, political affiliation or political philosophy. We welcome people from non-linear/non-traditional experience and educational backgrounds to join our team. Should a candidate be offered the position, they will need to show documentation of the ability to work in the U.S. including completing an I-9. We will also conduct background checks including a criminal history record check, and when appropriate, a financial and/or motor vehicle history check. 

TO APPLY: 

Interested applicants should send their resume to essence.rodriguez@mtek.com.