- 2-4 years as a Sr. Manager of Quality (special focus on design and customer quality), Design Assurance and/or R&D function or equivalent experience
- Previous experience at the Director level preferred but not required BS in Engineering or other relevant field of study
- Minimum of 10 years experience in a manufacturing and product development environment (Medical Device experience highly desired)
- Prefer 15 years full time work experience Master's Degree or equivalent preferred.
- Six Sigma experience, CQE/CQM/PE certification preferred.
- Formal training in Quality Systems.
- Must be able to communicate with large groups of people.
- Must be able to review printed materials.
- Must be able to generate and explain detailed proposals, guidelines, and procedures for the Quality function to departmental and/or non-departmental personnel.
- Must be able to analyze and resolve non-routine product issues using independent judgment.
- Must be able to routinely make decisions which affect immediate operations and may have a company-wide effect.
- Must be able to observe and correct minute inconsistencies (e.g. in the printed word, a production process, product appearance, etc.).
- Must be willing to travel (25%) and spend time in the operating room, cadaver and animal labs and visit customers or teams in other geographies as needed
- Excellent analytical skills.
- Excellent interpersonal skills.
- Demonstrated effective managerial skills.
- Excellent organizational skills.The Director of Quality Assurance will:
- Provide a strategic direction and tactical focus to the Quality Assurance organization and influence the direction of divisional QA activities (specifically Design and Customer Quality)
- Own cradle to grave (Pre and Post Market) from New Product Development to obsolescence, quality of all products in the business
- Launch new products with high quality and ensure quick resolution to quality issues on launched products as well as work closely with several functions including salesforce, marketing, R&D, product engineering, field service, operations, Project management etc.
- Ensure that manufacturing, product development, and related functions are conducted in compliance with international standards and government regulations in support of company mission.
- Establish standard process to ensure appropriate resolution and management of the responsible task owner.
- Chair meetings required to drive closure of quality issues.
- Manage and provide updates for quality metrics.
- Implement appropriate enhancements.
- Review regulatory compliance requirements for changes affecting device manufacturing in global markets.
- Support quality system changes to support evolving regulations and international standards.
- Represent quality processes during internal and external audits.
- Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets.
- Recruit, select, and on-board top talent.
- Develop talent within team to increase performance.
- Actively address performance issues on team.
- Maintain a high level of team engagement.Compensation:
$240,000 - $265,000 annually
If you are having difficulty in applying or if you have any questions, please contact Julia Ahadi at (+1) or
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
INDCQA
-
Employee Quality Assurance
Found in: Orion Innovations US - 1 week ago
Velocity Ventures Campbell, CA, United States Freelance**Quality Assurance Associate (m/f/d) - Ref.No. 22L139** · Microcoat Biotechnology GmbH is a growing and forward-thinking biotech company located in Bernried am Starnberger See. Currently, we employ approximately 220 employees. Our diverse range of activities includes the develop ...
-
Quality Assurance Specialist
Found in: SonicJobs Direct Apply US - 5 days ago
Actalent San Mateo, United States Full timeDescription: · Main responsibility is review and release of executed batch records coming out of contract mfg / packaging vendors. Primarily packaging. These >100pages BRR. · Perform review/release of executed batch records. · Perform review/approval of various packaging docu ...
-
Quality Assurance Specialist
Found in: SonicJobs Direct Apply US - 5 days ago
Actalent San Mateo, United States Full timeDescription: · Main responsibility is review and release of executed batch records coming out of contract mfg / packaging vendors. Primarily packaging. These >100pages BRR. · Perform review/release of executed batch records. · Perform review/approval of various packaging docu ...
-
Quality Assurance Specialist
Found in: SonicJobs Direct Apply US - 5 days ago
Actalent San Mateo, United States Full timeDescription: · 20% BRR · 80% Analytical focused · • Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements · • Serves as QA Lead for clinical and commercial projects. · • Leads quality investigations/deviations/ ...
-
Quality Assurance Specialist
Found in: Appcast US C2 - 1 day ago
Medix™ San Jose, United StatesMedix is currently hiring for a Quality Specialist to partner with a client through at least the end of the 2024 year Do you have a background in QA supporting a biotech, med device or pharma manufacturing group? If so, consider applying today. · Primary Responsibilities: · Perf ...
-
Director of quality assurance
Found in: Lensa US 4 C2 - 3 days ago
Randstad San Jose, CA, United StatesJoin our team as a Director of Quality Assurance and take the lead in ensuring our commitment to delivering top-quality products with efficiency and excellence. With a competitive salary ranging from $160k to $200k, you'll Work 6am to 2:30pm Schedule, Monday through Friday, with ...
-
Director of quality assurance
Found in: Lensa US 4 C2 - 3 days ago
Randstad San Jose, United StatesJoin our team as a Director of Quality Assurance and take the lead in ensuring our commitment to delivering top-quality products with efficiency and excellence. With a competitive salary ranging from $160k to $200k, you'll Work 6am to 2:30pm Schedule, Monday through Friday, with ...
-
Quality Assurance Specialist
Found in: Appcast Linkedin GBL C2 - 18 hours ago
Medix™ San Jose, United StatesPrimary Responsibilities: · Perform investigations per established procedures · Support problem solving and troubleshooting as part of investigations · Generate quality records as needed (CAPAs, CCs) to support process improvements · Review laboratory records (test packets, logbo ...
-
Director of quality assurance
Found in: Lensa US 4 C2 - 2 days ago
Randstad San Jose, United StatesJoin our team as a Director of Quality Assurance and take the lead in ensuring our commitment to delivering top-quality products with efficiency and excellence. With a competitive salary ranging from $160k to $200k, you'll Work 6am to 2:30pm Schedule, Monday through Friday, with ...
-
Director, Quality Assurance
Found in: Lensa US 4 C2 - 3 days ago
Super Micro Computer, Inc. San Jose, United StatesJob Req ID: 23300 · About Supermicro: · Supermicro is a Top Tier provider of advanced server, storage, and networking solutions for Data Center, Cloud Computing, Enterprise IT, Hadoop/ Big Data, Hyperscale, HPC and IoT/Embedded customers worldwide. We are the #5 fastest growing c ...
-
Supervisor, Quality Assurance
Found in: ZipRecruiter Test10S US C2 - 17 hours ago
iXSystems San Jose, United StatesJob Description · Job DescriptionSalary: $80,000 to $95,000 USD Annually · iXsystems is looking for a Supervisor, Quality Assurance to join our Quality team This position will report to the Director of Quality. As a supervisor at iXsystems, you will be instrumental in upholding t ...
-
Quality Assurance Engineer
Found in: Lensa US 4 C2 - 1 day ago
Tik Tok San Jose, United StatesResponsibilities · About TikTok: · TikTok is the leading destination for short-form mobile video. Our mission is to inspire creativity and bring joy. TikTok has global offices including Los Angeles, New York, London, Paris, Berlin, Dubai, Singapore, Jakarta, Seoul and Tokyo. · ...
-
Employee Quality Assurance
Found in: Orion Innovations US - 1 week ago
Infinity Systems Pleasanton, CA, United States Freelance"Take your career to the next level with Pleasanton, CA. · RONALGROUP - Leader in lightweight wheels. · When it comes to lightweight wheels, no one can compete with us - as the market leader and partner of all renowned car brands, we set new standards with our innovations and com ...
-
Director of Quality Assurance
Found in: beBee S2 US - 3 weeks ago
Proclinical Staffing San Jose, United States Full timeDirector of Quality Assurance - Permanent - OnsiteProclinical Staffing is seeking a Director of Quality Assurance to join an innovative medical equipment organization. This is a permanent role located in San Jose, CA. · Skills & Requirements:2-4 years as a Sr. Manager of Quality ...
-
Director, Quality Assurance
Found in: Lensa US 4 C2 - 3 days ago
Super Micro Computer San Jose, CA, United StatesJob Req ID: 23300 About Supermicro: Supermicro is a Top Tier provider of advanced server, storage, and networking solutions for Data Center, Cloud Computing, Enterprise IT, Hadoop/ Big Data, Hyperscale, HPC and IoT/Embedded customers worldwide. We are the #5 fastest growing comp ...
-
Senior Localization Quality Assurance
Found in: Lensa US 4 C2 - 2 days ago
Zortech Solutions San Jose, United StatesZOR Senior Localization Quality Assurance (LQA) Lead -US[San Jose, CA, , California, United States|Posted-15/04/2024Job Title: Senior Localization Quality Assurance (LQA) Lead (Contract)Location: San Jose, CA (Partial Onsite)Job Summary:We are seeking a highly skilled and experie ...
-
Quality Assurance Lead
Found in: Appcast US C2 - 18 hours ago
Astir IT Solutions, Inc. Santa Clara, United StatesRole : QA Lead · Location : Santa Clara, CA(Onsite) · Minimum 9+ Years of Experience required · Mandatory skills: Selenium,Automation,Groovy,Java,Coding,SQL,Spark,S3,Dynamo DB, Testing ,GIT,JIRA · JD: · Automation experience with groovy and Java coding skills SQL query skills · S ...
-
Senior Quality Assurance Engineer
Found in: Lensa US 4 C2 - 3 days ago
ESR Healthcare San Jose, United StatesSenior Quality Assurance Engineer - Medical Device San Jose, CA ref · Skills: Quality Assurance, Engineering, Medical Device, · • Experience with FDA Quality System Regulations and ISO Standards (ISO 13485 and ISO is required, · • Experience with non-conformances, CAPA, and Ri ...
-
Sr. Quality Assurance Engineer
Found in: Lensa US 4 C2 - 5 days ago
EPM Scientific San Jose, United StatesTitle: Senior Quality Assurance Engineer · Location: San Jose, CA (Onsite) · Compensation: Starting at $140,000 · Summary: I've recently partnered with the Head of QA of a medical device company in San Jose with a diverse portfolio of innovative products; one of which is a wea ...
-
Senior Quality Assurance Specialist
Found in: Lensa US 4 C2 - 5 days ago
Kymanox San Jose, United StatesSenior Quality Assurance Specialist (Contract) · You want to make a difference and have an impact... · You enjoy having an influence in your day to day work... · You are motivated by working alongside a team filled with · subject matter experts that will help you learn and gr ...
Director of Quality Assurance - San Jose, United States - Proclinical
Description
Director of Quality Assurance - Permanent - Onsite
Proclinical Staffing is seeking a Director of Quality Assurance to join an innovative medical equipment organization. This is a permanent role located in San Jose, CA.
Skills & Requirements: