Quality Assurance Manager Medical Device
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Job Location:
San Jose, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
11 hours ago
Vacancies:
1 Vacancy
Job Summary
This position is Responsible for leading Quality Assurance Department in accordance with vision values and strategic goals of the company. It will involve overseeing and facilitating efficient quality operations assuring consistent client service implementing laboratory practices as applicable to current regulatory standards working with client and agency audits and correspondence maintaining certifications Quality Assurance policy development and maintenance following up promptly on any quality and compliance related issues and implementing respective CAPA actions to assure adherence to the required quality metrics. Other responsibilities are as follows:
- Manage QA QC Regulatory and Compliance activities to help achieve quality/business goals as outlined in the Quality Manual Policy and SOPs to assure compliance with all applicable Standards and Regulations from all local state federal and international sources.
- Monitor for trends identify improvements and assure the effectiveness of the Quality Management System
- Implements prepares and presents training programs as required to satisfy regulatory requirements
- Applies industry experience to establish and implement best laboratory practices and quality system standards as related to compliance
- Performs QA review and approvals as required
- Maintains current records for required certifications and/or accreditations
- Communicates with client and agency auditors responds to findings and effectively addresses concerns or findings
- Provides information for monthly/quarterly reports to senior site management
- Identifies implements and assures adherence to effective quality control measures
- Mentors QA staff and provides leadership through demonstration of the vision values and strategic goals of the company
- Leads complex projects through to completion
- Communicates effectively with client staff members
- Performs other duties as assigned
Qualifications :
- Authorization to work in the United States indefinitely without restriction or sponsorship
- Bachelors or Masters degree in science field from a four year college/university or equivalent education and job experience
- At least five years of medical device (preferred) /biopharmaceutical experience with some data review responsibilities and a working knowledge of regulatory requirements
- Solid understanding of chemistry/lab practices.
- Knowledge of auditing techniques
- Self-confidence leadership ability to reason make sound decisions and delegate
- Empathy and sensitivity towards others
- Motivation to excel and inspire excellence in others
- Ability to manage the work of others and see projects through to completion
- Strong communication including verbal writing and presentation skills
- Ability to communicate effectively and relate well to people
- Mental and emotional stability and maturity
- Ability to handle personal stress and diffuse stress in others
- Strong organizational skills and ability to handle multiple priorities
- Sets positive example for others
- Dedication to quality ethics and customer service
- Pride in appearance conduct and company
- Ability to work effectively under pressure to meet deadlines
- Good negotiation and reasoning skills
- Excellent written and verbal communications skills
- Good judgment and tact recognizing and solving problems
- Recognized as understanding interpreting and following company policy
Additional Information :
Position is full-time Monday-Friday 8 a.m.-5 p.m. with overtime as needed. Candidates currently living within a commutable distance of San Jose CA are encouraged to apply.
Target compensation: $80000-$100000/year
Excellent full-time benefits including:
- Comprehensive medical coverage dental and vision options.
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time
Key Skills
About Company
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and the environment safer, healthier and more sustainable. From the food you eat to the medicines you rely on, Eur ... View more
