Senior Specialist, Quality Management Systems - Document Control
Axsome Therapeutics IncSalary not specified
Full Time
Senior (5 to 8 years)
Not SpecifiedCompensation
Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Medical Devices, HealthcareIndustries
Requirements
- High School Diploma or equivalent (United States), Level 5 Certificate or equivalent (Ireland), or EQF Level 4 or equivalent (EU)
- Minimum of 4 years in a Quality/Regulatory Affairs environment with 2 years in Document Control or related function, or 0-1 year in Quality/Regulatory Affairs with Bachelor’s Degree or equivalent
- Strong communication skills and ability to manage multiple tasks
- Ability to work independently
- Ability to comprehend verbal and written instructions and prepare written procedures and reports
- Ability to work well in a team environment at multiple levels
- Experience in ISO 13485, MDSAP, and CFR Part 820 Quality System Regulations (desired)
Responsibilities
- Control, review, release, archiving/storage, and obsolescence of documentation for Stryker site(s), including procedures and specifications
- Support site periodic reviews, CIDTs, and post-release tasks to ensure completion per regulatory requirements and standards
- Manage all activities related to document routing, distribution, and release to ensure latest effective copies are available
- Ensure prompt archiving and storage of applicable Stryker documentation
- Provide timely retrieval of documents and information for investigations, audits, and/or reports
- Provide coaching, guidance, and support to functions in use of and navigation of the PLM system and execution of documentation & change processes
- Identify improvement opportunities within PLM-related processes and participate in improvement initiatives
- Act as single point of contact for process owners during implementation of external Stryker documents into local QMS, including CIDT process
- Report on and input quality KPIs for Stryker site(s), including periodic review, CIDT process, supplier notifications, and change activity RFT for trending/management reviews
- Support issue investigations and provide input to correction & resolution, rework, problem solving, and process improvements
- Assist with company regulatory audit activities as necessary
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What is the work arrangement for this position?
The position offers hybrid work flexibility.
What experience is required for this role?
Candidates need a minimum of 4 years in a Quality/Regulatory Affairs environment with 2 years in Document Control or related function, or 0-1 year with a Bachelor’s Degree or equivalent. Desired experience includes ISO 13485, MDSAP, and CFR Part 820 Quality System Regulations.
What are the key skills needed for this job?
Strong communication skills, ability to manage multiple tasks, work independently, comprehend instructions, prepare written procedures and reports, and work well in a team environment are required.
What is the salary or compensation for this position?
This information is not specified in the job description.
What education is required for this role?
A High School Diploma or equivalent is required in the United States, Level 5 Certificate or equivalent in Ireland, or EQF Level 4 or equivalent in the EU. A Bachelor’s Degree or equivalent can reduce the experience requirement.
Stryker
Develops and manufactures medical devices and equipment
About Stryker
Stryker develops and manufactures medical devices and equipment aimed at improving patient care and surgical efficiency. Their products include surgical tools, neurotechnology devices, and orthopedic implants, which are sold directly to hospitals and clinics. Stryker stands out from competitors by focusing on high-quality products and a commitment to advancing healthcare solutions. The company's goal is to enhance the overall healthcare experience for both patients and medical professionals.
Kalamazoo, MichiganHeadquarters
1941Year Founded
$423.3MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees
Benefits
Medical & prescription plans
Supplemental health benefits
Flexible Spending accounts
Employee Assistance Program
Short-term & long-term disability
Tuition reimbursement
401(k) plan
Employee Stock Purchase Plan
Risks
Integration challenges from acquisitions may strain Stryker's resources.
Rapid tech advancements risk obsolescence of Stryker's current products.
Regulatory scrutiny on acquisitions could delay Stryker's market entry.
Differentiation
Stryker's acquisitions enhance its minimally invasive surgical solutions portfolio.
Entry into the peripheral vascular segment diversifies Stryker's market presence.
Stryker's focus on AI integration boosts diagnostic accuracy and operational efficiency.
Upsides
Growing demand for minimally invasive solutions aligns with Stryker's strategic acquisitions.
The orthopedic implants market growth benefits Stryker's expanding product line.
Stryker's acquisition of Inari Medical positions it in a high-growth vascular market.
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