137 applicants
Precision For Medicine · 2 days ago
Quality Assurance Specialist - Design Control
United States
Contract
Remote
Mid Level
$75K/yr - $110K/yr
4+ years exp
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Responsibilities
Support the maintenance and review of DHF and actively participate in all Design Control activities pertaining to the CDx projects including risk management, acceptance of customer specifications, and change control.
Lead Design Control with cross-functional teams such as Operations/ Research/ Project Management/ Regulatory Affairs/ IT.
Assist in the QA review and acceptance of customer specifications to conform to contractual requirements.
Assure product compliance to regulations, standards, and quality systems in accordance with CAP/CLIA, ISO9001, ISO13485, and ISO15189
Proactively identify opportunities for improvements in areas of system compliance
Serve as quality reviewer and approver for design control changes.
Responsible in maintaining established companywide GxP quality systems, actively managing assigned activities (including logging and tracking of events and outcomes), and working with end-users on thorough documentation of quality system events including: Non-Conformances, Customer Complaints, Planned Deviations, Change Management, Corrective and Preventive Action (CAPA), Audit Programs
Participating on the Material Review Board
Assist in scheduling, performing, and reporting internal audits, as well as supplier audits, and related activities, as needed.
Manage the backroom during audits and inspections, review requested documentation and records, and assist in preparing subject matter experts for audit interviews. Support due diligence as well.
May be involved in the issuance of Certificates of Analysis for finished products and products for resale.
Work with functional groups to develop correct documentation required to document evidence for the manufacturing/processing, testing and release of products and services.
Maintain filing and storage systems for document control, training, and batch records for raw and finished product.
Collaborating with Project Management to plan upcoming quality deliverables and enforce compliance accountability.
Provide Quality oversight for the Design Control, and Commercial stage, including Design Transfer.
Responsible for Risk Management with DHFs.
Create/revise/execute SOPs to support combination product quality governance in the commercial stage.
Participate in quarterly and annual management review as well as periodic product reviews.
Perform periodic review and update of DHF and RMF.
Accountable for Design Control QMS processes.
Provide guidance to junior level QA specialists.
Client-facing activities as assigned by department head such as leading client visits/audits and representing QA during project kick-off meetings
Support validation activities, including review and approve validation protocols, reports, and final package documentation.
Assist in the QA review and acceptance of customer specifications to conform to contractual requirements.
Serve as SME during regulatory inspections
Qualification
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Required
Bachelor’s Degree or equivalent combination of education and experience
4 years of related experience in a life science, regulated environment
In-depth knowledge and hands-on experience with products designed and commercialized under ISO 13485, ISO14971, and 21CFR Part 820 standards
Experience with IVDR, ISO15189, CAP/CLIA
Experience working in a Quality Department/Life Sciences-Regulated environment, including experience independently conducting internal audits, document review from a technical and quality perspective, batch release, incoming inspection
Knowledge of root cause analysis tools and application, identifying durable corrective/preventative actions, and participating in process improvements
Ability to meet deadlines and perform administrative functions
Microsoft Office suite proficiency including Office Word, Excel, PowerPoint
Ability to organize tasks, work independently and adapt to changing priorities
Ability to function independently within a minimally supervised environment with exceptional attention to detail required
Demonstrated highly developed communication skills including well-developed writing skills and verbal and interpersonal skills
Must be able to read, write, speak, fluently and comprehend the English language
Benefits
Discretionary annual bonus
Health insurance
Retirement savings benefits
Life insurance and disability benefits
Parental leave
Paid time off for sick leave and vacation
Company
Precision For Medicine
Precision for Medicine is a specialized scientific services company helping life science innovators develop medical products. It is a sub-organization of Precision Medicine Group.
1,001-5,000 employees
H1B Sponsorship
Precision For Medicine has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2022 (2)
2021 (1)
2020 (1)
Funding
Current Stage
Late StageTotal Funding
$225M2015-12-22Private Equity· $75M
2013-04-02Private Equity· $150M
Leadership Team
Jared Kohler
Sr. Vice President, Project Management & Data Science Operations & Precision for Medicine
Jay Lezcano
SVP & Business Development
Recent News
2024-06-03
Company data provided by crunchbase
