Skip to content
CV Rocket
Get started
How it worksThe enginePricingBlogContactSign in

Open nowPosted 44 days ago

Quality Assurance Director

medplast90 open roles

Where
Fremont, CA, USA
Get the CV for this job

From $25 per CV, paid once. No subscription.

Your applicationOpen nowQuality Assurance Directormedplast · Fremont, CA, USA

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on medplast's own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

7.8% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 1.7%1 day
  2. 3.5%3 days
  3. 7.8%7 days
  4. 14.6%14 days
  5. 34.1%30 days
This job: posted 44 days ago

The posting

About the company: Viant is a global medical device partner providing design, development, manufacturing, and assembly services through capabilities in materials, plastics, metals, extrusion, and automation. With nearly 6,000 employees across 24 locations worldwide, it delivers high-quality, life-enhancing products with the scale and expertise to bring devices to market efficiently. Learn more at Viant Medical’s website or on LinkedIn. About the site: This Fremont-based center focuses on product design and development, supporting engineering innovation, prototyping, and process development for complex medical devices. About the role: The Director of Quality Assurance is a senior, highly responsible leadership role overseeing all aspects of the Quality Management System (QMS). In this role you will Lead and develop a team of approximately 15 Quality Engineers supporting both product development and manufacturing operations. This position requires strong expertise in medical device manufacturing, customer engagement, regulatory compliance, and organizational leadership, with deep knowledge of quality systems in accordance with FDA 21 CFR 820 and ISO 13485. The Director will lead strategic quality initiatives, ensure regulatory compliance, drive continuous improvement, and serve as a key partner to internal teams, customers, and suppliers. Essential duties and responsibilities:

Provide strategic leadership for all Quality Assurance programs and policies to strengthen and continuously improve internal and external quality. Lead the Quality Assurance department in the design, implementation, and maintenance of systems for document and data change control, training, CAPA, discrepancy handling, and complaint handling. Provide guidance to all departments on quality and regulatory requirements. Develop and maintain quality system procedures related to Quality department responsibilities. Lead Quality Assurance and Regulatory Affairs review and approval of quality system documentation. Manage the Quality Engineering support function and provide indirect support to Quality Inspection teams. Partner closely with management to ensure adherence to documented processes and development of key performance indicators (KPIs). Collaborate with customers and suppliers on quality-related matters while maintaining strong business relationships. Direct the selection, training, and development of Quality personnel in accordance with company policies. Coach, mentor, train, develop, and evaluate Quality Improvement personnel. Maintain a robust Quality Management System compliant with FDA 21 CFR 820, ISO 13485, and customer requirements. Ensure customer satisfaction with product quality. Manage communications and documentation related to part revisions, holds, dimensional inquiries, rejections, changes, qualifications, validations, audit data, and other customer-required quality information. Review, interpret, and implement customer-required corrective actions for product quality issues. Implement process and procedure changes to improve product quality. Oversee internal and external audits, as well as CAPA programs.

Qualifications:

Bachelor's degree in Engineering, Quality, or related field.  10+ years of Quality experience in a regulated manufacturing and development environments (Medical Device, Pharmaceutical, Biologics) 5+ years leading Quality teams.  Medical Device industry experience required. (Must) Strong knowledge of FDA, ISO 13485, CAPA, NCR, and audits.  Experience leading Quality Engineers in development and manufacturing environments. Customer-facing quality leadership experience.  Experience driving quality system improvements and audit readiness. Knowledge of process validation, sampling plans, and statistics.  Strong leadership, communication, and team development skills. Must have aptitude to develop a functional and technical understanding of products to ensure that manufacturing and inspection processes are adequate to ensure appropriate product performance.

Preferred Qualifications

ASQ certification (CQE, CQA, CMQ/OE). Knowledge of Quality Management Systems (QMS), SPC, statistics, GMP, and GLP.

Skills:

Strong written and verbal communication skills, with the ability to be an effective and persuasive speaker and negotiator. Ability to apply rational systems principles to solve practical problems and manage diverse variables in environments with limited standardization. Ability to interpret and execute instructions provided in written, verbal, diagrammatic, or schedule formats. Proficient in basic computer operations, including email, record keeping, and routine database activities, with advanced skills in word processing, spreadsheets, and graphics software. Strong people management skills, including counseling, coaching, performance evaluation, and team leadership.

Benefits:

Medical, dental, and vision benefits-effective date of hire! Company-paid life insurance and disability benefits Generous Paid time off and 10 paid Holidays 401k Plan with Company Match Tuition Reimbursement Voluntary Universal Life and Long-Term Care Voluntary Legal Plan Pet Insurance Home Ownership Program

We offer market competitive compensation. Potential salary range for this role is $200k-$240k. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law

From $25, paid onceGet the CV for this job

What happens when you press

One press. We do the rest.

  1. A CV for this posting

    Written against medplast's own wording, from every piece of relevant proof in your profile.

  2. 25 readers review it

    Recruiter, hiring manager, skeptic and more read every draft, round after round. You get the best round.

    The review screen in CV Rocket: how each CV was read, round by round.

  3. We apply on medplast's form

    Our application engine gets through the hardest forms there are. Where a question needs you, AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

    An application in CV Rocket: every answer filled in on the employer's form.

  4. Every reply, sorted

    medplast's answer lands in your private mailbox, and we classify it on arrival: interview, question, rejection.

    The CV Rocket inbox: each employer reply classified as an interview, an action or a rejection.

  5. Reply with AI

    AI helps you write the email, checks it and sends it. We show you whether the recruiter read it.

  6. The interview in your calendar

    Full integration with your calendar. The invitation goes straight in.

    An interview invitation in the CV Rocket inbox, added to the candidate's calendar.
Get the CV for this job

From $25 per CV, paid once. No subscription.

Why it works

3×

more interviews than doing it yourself with ChatGPT.

ChatGPT writes a CV and never learns what happened to it. We see every reply. For each CV we know:

  • How it was written, and how the review scored it
  • When we applied, and how long after the posting went up
  • Which posting, which company, which city
  • Who got the interview, and who heard nothing

That is how we know which CVs get called.

Get the CV for this job

From $25 per CV, paid once. No subscription.

The numbers game

More applications. More interviews.

Every application goes out with its own CV, written for that posting and paid once. Send enough of them and the law of large numbers finds you the job.

Get the CV for this job
By hand5–10
With CV Rocket100
applications a day

Nearby

Live postings like this one

Same employer first, then the same role elsewhere.

Before you press

Straight answers

Get the CV for this job

From $25 per CV, paid once. No subscription.

What if my background isn't good enough?

We make the most of the background you have. The CV uses every piece of relevant proof your profile holds, and one of the 25 readers reads your whole profile and flags what the CV left out.

Do you really apply for me?

Yes, on the employer's own form, the hardest ones included. Where a question needs you, you answer it right there and AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

Is it a subscription?

No. You pay once per CV, from $25. Every application goes out with its own CV, written for that posting.

One job. One CV.
Paid once.

Pick the posting you want. We write for it, apply for you and catch the reply.

Get the CV for this job

From $25 per CV, paid once. No subscription.