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Quality Manager Jobs

Company

Alio, Inc
Address , Broomfield
Employment type FULL_TIME
Salary $111,000 - $151,000 a year
Expires 2023-11-18
Posted at 8 months ago
Job Description

Alio, Inc. is a medical technology company bringing peace of mind to people with chronic conditions through non-invasive, wireless remote patient monitoring. Currently, Alio uses its SmartPatch™ technology to monitor individuals with end stage kidney disease (ESKD) undergoing dialysis. Alio's platform uses artificial intelligence (AI) to analyze data and create actionable insights. These insights enable targeted interventions with the potential for improved health outcomes and reduced hospitalizations. Alio has built a team of seasoned leaders with diverse backgrounds spanning across industries and segments such as medical devices, wearable technology, government relations, commercialization, and reimbursement. Visit our website for more information: https://alio.ai.

Description

The Role
The Quality Manager will be an integral part of the Quality Assurance and Compliance organization. This role will support Engineering and other functions daily while also holding key Quality positions. The role is responsible for management of the CAPA process, including key metrics to ensure success of the process. In addition, the Quality Manager will assemble and maintain the Design History File and shepherd the team through the Design Controls phase gate process. The Quality Manager is responsible for managing the Document Control and Training functions within Quality.

The role reports to the Director of Quality.

This position will be expected to work out of the Broomfield, CO office 2-3 times per week and travel regularly to our office in San Francisco, CA.

What you’ll do

  • Failure analysis for internal and external failures, including those stemming from complaints and returns
  • Document control and training oversight
  • Design controls oversight
  • Root cause investigation
  • Design V/V and process validation oversight
  • Audit support
  • NC and CAPA management
  • MDR transition support
  • DHF index management


Who you are

  • Attention to detail
  • Ability to understand and interpret standards and regulations
  • Prior experience managing staff
  • 5+ years of experience in a Quality role within the medical device industry
  • B.S. degree in a science field (Engineering, Software, Chemistry, etc.)
  • Ability to work on site 2-3 days per week in Broomfield, CO
  • Ability to work collaboratively in teams
  • 1+ years of experience managing others (project mgmt or direct reports)
  • Ability to travel as needed (%), both domestically and internationally
  • Management of audits or prior support of audits, especially ISO 13485
  • 3+ years of experience in Software as a Medical Device (SaMD)
  • Knowledge of and experience with global medical device regulations including ISO 13485, 21 CFR Part 820, 14971, 10993, 60601, 62304, etc.

Bonus Qualifications

  • Expertise in assembling documentation to support regulatory submissions
  • Experience transitioning from MDD to MDR for EU compliance
  • Experience with Greenlight Guru QMS


What you’ll get

  • Fertility, parenting, and menopause support and reimbursement through Maven
  • Unlimited Paid Time Off - Recharge when you need to without worrying about how much time you have left in a bank of hours.
  • Meaningful Stock Options
  • Medical, Dental, Vision, HSA and FSA with generous or 100% employer contributions
  • 401k

Salary

$111,000 - $151,000 per year